Dr. Susan Potter
Dr. Mark Johnston
Please read the following information carefully and contact the researchers at firstname.lastname@example.org if you have any questions. At the bottom of this page, you will find a link to the eligibility questionnaire.
You and your child have been invited to participate in a study examining the effects of probiotics, consumed with dairy products, on the symptoms of attention deficit-hyperactivity disorder (ADHD), anxiety disorders, and related physiological and psychological factors.
Each individual’s gut contains many different strains of bacteria, which together form the gut microbiome. The microbiome consists of both good and bad bacteria, and it influences many processes in a person’s body, such as nutrient absorption, body weight, normal development, and brain functioning. Probiotics are the good bacteria that exist within the gut microbiome and they are also present in some foods. Factors such as antibiotics, diet, cesarean birth, prolonged stress, and illness can affect the composition of one’s microbiome and cause imbalances. Imbalances among gut bacteria are associated with digestive disorders such as irritable bowel syndrome and Crohn’s disease; but gut bacteria also influence brain functioning. Microbiome disturbances have been linked to autism, depression, anxiety, and may also influence ADHD symptoms. One way that gut bacteria may exert their effects is through their influence on the regulation of a stress hormone called cortisol. Cortisol is often elevated in individuals with anxiety but low in those with ADHD. Eating foods that contain probiotics is thought to help restore proper balance within the gut, which in turn may have a positive effect on brain functioning and cortisol levels, thereby improving symptoms of anxiety and ADHD.
The current study will examine the effect of a probiotic supplement consumed with milk or ice cream on the symptoms of ADHD and anxiety in children. The main goal is to determine if probiotics might be useful as a treatment for anxiety and ADHD symptoms in children. A second goal is to examine the effects of probiotics on saliva cortisol levels. Finally, we are also interested in the effects of the probiotics on children’s digestive health. This research is being conducted by Dr. Susan Potter, a clinical psychologist and associate professor in the Department of Psychology at Acadia University and Dr. Mark Johnston, a psychiatrist at True North Clinical Research in Kentville and Halifax. This research will also contribute to student theses at Acadia University.
In order to participate in this project, your child must be between the ages of six and seventeen years and be exhibiting inattentive, hyperactive, and/or anxiety symptoms that are causing some degree of difficulty for him or her at school and at home. You must live within reasonable driving distance of Wolfville or Halifax; you and your child must be able to meet with a researcher at Acadia University, your child’s school, or a clinic in Halifax three times during the study period (at the beginning, middle and end of the study - approximately every four weeks). You will need access to the internet and an email account that you check regularly. Your child must already drink milk with no adverse health effects (children who are dairy intolerant cannot participate). Children diagnosed with cancer, AIDS/HIV, Crohn’s Disease, active ulcerative colitis, or any other serious illness cannot participate (less serious digestive disturbances such as irritable bowel syndrome are permitted).
4. Overview of the Study
If you are interested in having your child participate in this research study, and you have not already visited the study website, http://probioticstudy.com, please visit the study website and complete the online questionnaire asking about your child’s ADHD and anxiety symptoms, health, medical history, and diet. If your child is eligible to participate, you will be contacted by one of the researchers to schedule an appointment to meet, either at Acadia University in Wolfville, your child’s school, or a clinic in Halifax (Roth & Associates). At this meeting, the study procedures will be explained to you and you will be given the materials you need for the study. You will be asked to complete some questionnaires asking about your child’s behavior and ADHD and/or anxiety symptoms. You will complete some of these questionnaires again at the end of each phase of the study so we can determine if there has been any change in your child’s symptoms. With your permission, your child’s teacher will also be asked to complete some questionnaires regarding your child’s behavior and ADHD and/or anxiety symptoms at school.
The study will be carried out over an thirteen-week period. The first week is an information-gathering week during which your child will complete a daily food diary with your assistance (that is, they will be asked to write down what they ate each day) and answer a few questions about his/her bowel health, anxiety, and ADHD symptoms. Following this week, your child will consume either probiotics powder or a placebo powder (an inactive substance with no health effects) once each day for four weeks, taken with either milk or ice cream. This will be followed by a four-week “wash-out” period (no probiotic or placebo), then they will switch and take the other, probiotic or placebo, (whichever they did not receive during the first four weeks) for four weeks. Throughout the study period, you and your child will be asked to answer a few questions about your child’s mood and bowel health and the end of each week. Your child will be asked to provide a saliva sample four times over the course of the study, which will be analyzed for cortisol, an important stress hormone that may be influenced by anxiety, ADHD and probiotics.
You will be provided with enough probiotics/placebo to give your child every day in each of the four-week phases. You will also be provided with and $8 Sobey’s gift certificate when you meet with the researcher at the beginning of each four-week phase to help cover the cost of the milk or ice cream.
5. What is a placebo?
A placebo is an inert substance (sometimes called a “sugar pill”) that would not be expected to have any health effects. A “placebo effect” is an improvement in health, or sometimes the experience of side-effects, that cannot be attributed to a treatment (i.e., it occurs in response to a placebo). Placebo effects often occur when a person believes they are taking an active treatment and, as a result, expects or anticipates that it will have an effect. Therefore, it is important to have a “placebo control” in a study like this because if your child’s symptoms get better simply because they are taking something they hope will work (i.e., probiotics), we won’t know if the improvement was due to the probiotics or to your child’s expectations.
6. What will my child and I be asked to do?
Prior to your first meeting with the researchers, one of the researchers will contact you and explain the initial one-week information-collection period and an appointment will be scheduled for you to meet with the researchers. The researcher will explain to you how to keep an online food diary to keep track of what your child eats each day, and a few questions that we would like you to answer each evening about your child’s anxiety and ADHD symptoms and gut/bowel health during this information collection week. These can be completed online, but a paper option is available and can be mailed (or picked up) for those who would prefer. In addition, an appointment will be scheduled for you to meet with one of the researchers at the end of the information collection week. You will not have to complete the food diaries again, but you will continue to answer the questions about ADHD/anxiety symptoms and gut/bowel health at the end of each week of the study period. This part is described in more detail below.
A. One-week Information Collection Period
Each day for the first week you will help your child complete an online food diary (or paper version if online is not possible). You will be asked to list what he or she ate each day. The amounts don't need to be exact but it is important to list all foods and drinks consumed. This should take 5 to 10 minutes to complete.
Each evening, during this first week only, you will be asked to answer a few questions about your child’s overall anxiety/ADHD symptoms that day and he or she will answer a few questions about their bowel health (e.g., number and type of bowel movements). We are interested in gastrointestinal symptoms because of their strong association with anxiety, ADHD, and microbiome disturbances.
B. Initial Appointment
You and your child will be asked to come to our office to meet with one of the researchers. This appointment will be approximately one hour long. During this session, the following things will happen:
The study requirements will be explained to you and your child in detail and, if you and your child agree to participate, you will be asked to sign an informed consent form.
You will talk with the researcher about your child’s anxiety and/or ADHD, other mental health issues and any physical health problems he or she may have, and complete some questionnaires asking about these types of issues.
Your child will complete three activities designed to measure sustained attention, visual and verbal memory.
You will be given two saliva collection kits to take home. These consist of a small test-tube and straw that your child will put in his or her mouth and drool or spit into. Instructions on when and how to take the saliva samples are provided below. We will analyze the saliva samples for cortisol, a stress hormone, to see if probiotics have any effect on cortisol levels.
You will receive your child’s probiotics or placebo packets and an $8 Sobey’s gift card to help cover the costs of the milk or ice cream for the first four-week phase of the study.
Saliva Sample Collection
You will help your child collect his or her first saliva sample one morning shortly after meeting with the researchers, BEFORE beginning to take the probiotic or placebo powder. Instructions for saliva sample collection are as follows:
First sample(Labeled "#1"): You should collect your child’s first baseline saliva sample as soon as possible after your first meeting with the researchers, before beginning to take the probiotics or placebo. Do this first thing in the morning immediately after your child wakes up (have the kit ready the night before, in the child’s bedroom). They should not eat or drink anything until after you have collected the saliva sample. Write the date and time on the label. Follow the instructions with the kit provided. If his or her mouth is too dry, get him/her to try to imagine biting into a lemon or eating a favourite food. After collecting the sample, immediately place it in your freezer (deep freezer if you have one). Bring the saliva sample to your next meeting with the researcher.
Second sample (Labeled "#2"): Your child’s second saliva sample should be collected near the end of the first probiotic or placebo phase (do it during the last week, prior to your appointment with the researcher). As before, collect the sample first thing in the morning. Write the date on the label. Place the sample in your freezer.
Third sample (Labeled "#3"): Collect this as described above, at the end of your child’s four-week wash-out period (i.e., the four weeks during which they do not take the powder). Write the date and time on the label and put it in your freezer.
Fourth sample (Labeled “#4”): Collect this as described above, at the end of your child’s last four weeks in the study in which they take probiotics or placebo powder (during the last week, before your final meeting with the researcher). Write the date and time on the label and put it in your freezer.
Bring your saliva samples to your next meeting with the researcher. It is okay if the samples cannot be refrigerated for an hour or two, but try to keep them frozen for as long as possible.
C. First Four-week Probiotic or Placebo Phase
During this phase, your child will consume one packet of probiotics or placebo (whichever you were given) each day for four weeks.
To take the probiotic or placebo powder, your child should open the packet, tilt his/her head back, and pour the powder onto his/her tongue. He/she should then drink some milk (a half cup or more). Another option is to take the powder by mixing it with a small amount of ice cream. Try to give your child the probiotic/placebo at approximately the same time each day.
Neither you nor the researcher will know whether your child is taking probiotics or placebo -the packages all look alike (they will be identified at the end of the study).
The probiotic packages will contain a flavoured probiotic powder (Probio’Stick) that contains 3 billion live bacteria (cfu), produced by Lallemand Health Solutions. These probiotics are encapsulated to protect them from stomach acids so that they can travel to the intestines and colon where they are believed to exert their beneficial effects.
The placebo packages contain a flavoured powder that is inert (i.e., it will not have any effects on any of your child’s symptoms) that looks and tastes just like the Probio’Stick but does not contain any probiotics.
You and your child will answer the questions about the severity of your child’s anxiety/ADHD symptoms and bowel health at the end of each week.
You will receive emails from the researchers every few days during the first week to check in and see how your child is doing and answer any questions you may have. You will also receive an email at the end of each week with a link to the weekly questionnaire. It is very important to complete this questionnaire at the end of each week (i.e, don't put it off!).
Part way through this four-week period, you will be contacted by the researchers to set up your second appointment, which will take place near the end of the fourth week.
Towards the end of the fourth week of taking the probiotics or placebo, you will collect another morning saliva sample from your child, as before.
D. Second Appointment with the Researcher (End of first probiotic or placebo phase/Beginning of
four-week wash-out period)
Your second appointment with the researcher will take place when your child is within a few days of finishing the first supply of probiotics or placebo (remember to collect your second saliva sample on a morning shortly before this meeting). This appointment marks the beginning of the four-week wash-out period. Please remember to bring your frozen saliva samples with you.
This meeting should last about a half hour, during which:
You and your child will complete some of the questionnaires again that you completed at the beginning asking about your child’s anxiety/ADHD symptoms and physical health during the past week.
You will be given another saliva collection kit to collect a sample during the final week of this four-week wash-out period (use test-tube labelled “#3”).
Your child will complete the same three activities that he or she completed at the first appointment.
The next four weeks is the washout period – please make sure you wait the full four weeks before starting your child on their second round of probiotic or placebo packets.
E. Four-week Washout Phase
Researchers believe that when we consume probiotics, they do not colonize (set up house) in our gut, but move on out unless we keep taking them. The four-week wash-out period is necessary to make sure that probiotics taken in the first phase (for those who received probiotics first) have left your child’s body before moving on to the second phase.
During the four-week washout phase, you will continue to answer the questions about your child’s anxiety/ADHD and bowel health at the end of each week.
F. Third Appointment with the Researcher (end of four-week wash-out period/start of second
probiotic or placebo phase)
This phase is just like the first four-week phase, except that if your child took probiotics during the first phase, they will now take placebo, and if they took placebo during the first phase, they will now take probiotics.
As before, You will be given a four-week supply of probiotics or placebo and over the next four weeks, your child will consume one packet each day, with milk or ice cream. Try to have them take it at approximately the same time each day as in the previous phase.
At this appointment you will be given another saliva collection kit to collect a sample during the final week of this four-week period (use test-tube labelled “#4”).
You will be given an $8 Sobey’s gift card to help cover the cost of the milk or ice cream.
You and your child will continue to answer the questions about your child’s anxiety/ADHD symptoms and bowel health at the end of each week.
Your child will complete the attention/memory activities.
You will receive emails from the researchers every few days during the first week to check in and see how your child is doing and to answer any questions you may have.
Part way through this four-week period, you will be contacted by the researchers to set up your final appointment, which will take place close to the end of the last week.
As before, towards the end of the fourth week of this phase, you will collect another morning saliva sample from your child. Use the test-tube labeled “#4” and write the date and time on the label. After collecting the sample, place it in your freezer. Bring the sample with you to your final meeting with the researcher.
G. Final Meeting with Researcher
Your final meeting with the researcher will take place near the end of the fourth week of the second probiotic/placebo phase. At this meeting:
You and your child will complete the questionnaires again that you filled out at the last meeting, focusing on your child’s symptoms and behaviour during the previous week.
Your child will complete the attention/memory activities.
Any questions you have will be answered.
Your child will receive $50 for his/her participation.
7. What are the ingredients of the probiotic and placebo powder and will my child feel
any beneficial or adverse effects from taking them?
The probiotic powder is made up of the following ingredients: two strains of probiotics, Lactobacillus helveticus and Bifidobacterium longum subsp. longum (3*109 CFU per sachet), artificial fruit flavour, xylitol (sweetening agent), matodextrin (filler), and malic acid (acidifying agent). The placebo powder has the same ingredients minus the probiotics.
When your child is taking the probiotic powder, if it has a beneficial effect, you may notice an improvement in your child’s mood, anxiety levels, concentration, and behavior, and any digestive issues he or she may have had may get better. Some people report experiencing mild bloating and/or gas when they first begin taking probiotics, but these complaints are usually mild and subside within the first week or so.
On the other hand, because the placebo powder is an inert substance with no health effects, it will not cause improvements in your child’s mood, anxiety levels, concentration, behavior, or digestion. However, some children taking the placebo may experience a “placebo effect” and feel an improvement in their symptoms (or sometimes negative side-effects) that they will attribute to the powder, assuming (incorrectly) that it must be the probiotic.
We ask that you to tell your child’s health care provider that your child is taking part in this study.
8. What are the risks and advantages of participating?
There are no known risks associated with participating in this study. The probiotics have been studied before, are available over-the-counter in pharmacies and are generally considered safe. Some people may experience mild gastrointestinal side effects such as gas and bloating. It is possible that there are other risks of which we are not aware at this time. If we become aware of other risks, we will notify all research participants immediately. In the event that your child becomes ill or experiences any adverse reactions that you believe are caused by the probiotic or placebo powder, please notify the researchers immediately and stop giving your child the powder. Arrangements will be made for your child to be seen by Dr. Mark Johnstonat the True North Clinical Research in either Halifax or Kentville. If your child is seriously ill, take him or her to your family doctor or emergency department, and let them know that your child is participating in a probiotic study.
There will be no direct benefits to your child from participating in this study (other than a small financial compensation) because we do not know for certain that probiotics will help anxiety and depression, although the results of other past research are promising. However, your child will be contributing to the advancement of science and furthering our knowledge about the potential therapeutic effects of probiotics on ADHD/anxiety.
9. Can my child participate if they are taking other medications?
Please discuss this with your physician before enrolling in this study and please notify the researchers of any medications your child is taking. For the purposes of the research product, it is okay if your child is taking medications for ADHD/anxiety as long as they have been taking a stable dose for at least two months and the dose is unlikely to change during the study period. However, your child cannot participate if they are taking antibiotics, undergoing chemotherapy, or they are taking medications for HIV. There may be other medications that are also contraindicated so please discuss this with the researchers.
10. Will my child be paid for participating in this study?
As a token of our appreciation, each month that your child is in the study, your child will be entered into a draw for the chance to win a prize (e.g., movie passes, toys, gift certificates, etc valued at approximately $20).
If your child completes the study, he or she will receive $50 cash at the last meeting.
11. Will the milk or ice cream required in the study be provided?
You will be provided with an $8 Sobey’s gift card at the beginning of each phase to help cover the cost of milk or ice cream for that phase.
12. Can I withdraw my child from the study if we change our minds about participating?
You may withdraw your child or your child may withdraw from the study at any time for any reason. If your child withdraws, he or she will no longer be entered into the prize draws and will not receive the $50 compensation at the end. If you wish to withdraw your child’s data, you must notify the researchers within one week of your child completing the study or withdrawing from it. If your child withdraws from the study, we would appreciate it if you would let us know why; this is important for Health Canada monitoring purposes and it may help us to improve the design of future studies.
13. Can the researcher withdraw my child from the study?
You and your child may be withdrawn from the study by the researchers for failing to complete the required tasks; e.g., not completing the questionnaires, not taking the probiotics, missing appointments with the researcher, etc. If you are withdrawn by the researcher for not completing the required tasks, your child will not be entered into the prize draws and will not receive the $50 compensation at the end.
14. What should I do if my child refuses to take the probiotic or placebo powder or doesn’t want to complete his or her questionnaires?
Participation in this research is completely voluntary. We fully respect your child’s right to withdraw from the study. If, however, your child is having a bad day and you believe he or she may feel differently later on, ask him or her again a bit later or the next day. It is okay if your child misses a day as long as it happens only occasionally. Do not coerce or force your child to take the powder if he or she does not want to.
15. Will the information my child and I provide be kept confidential?
Once you have completed the online eligibility questionnaire and the researcher has contacted you, all identifying information (your child’s name, your name, and your contact information) will be removed from the server and you will be assigned a code number. From that point on, all your questionnaires and other data will be identified by code number only, except for teacher rating forms which will have your child’s first name until received by the researcher, at which point names will be removed and replaced with code numbers. Apart from this, neither your name nor your child’s name will appear on anything except the master code list and this will be stored separately in an encrypted, password-protected file on a password-protected computer. All online questionnaires will be housed on Canadian servers and your child’s data will be identified by code number only.
Contact information collected during this study will be used only for the purpose of this study and will not be shared with anyone.
Your child’s teacher will be asked to answer a few short questions asking about your child’s anxiety and ADHD symptoms at school. However, we will not share information we gather from you about your child with his or her teachers (unless you want us to and provide written permission), nor will we share with you information that your child’s teacher provides about your child (unless the teacher wants us to and provides written permission); that is, information your child’s teacher provides will be treated as confidential.
Saliva samples will be identified by code number only and will be analyzed by a technician in the Biology Department at Acadia University.
Although certain persons known as study monitors, auditors, and other regulatory authorities may be granted access to our research records for verification of clinical trial procedures and/or data, as required by Health Canada’s Good Clinical Practice Guidelines, the information they view will be identified by code number only; your child’s identity will not be revealed.
If you are completing online questionnaires about your child from your workplace, be aware that your employer is legally entitled to monitor electronic communications in the workplace, and could view your responses.
All information you and your child provide will be kept confidential, except where confidentiality must be waived by law (e.g., reports of child abuse, subpoenas, etc).
When the results of this project are presented at professional conferences, discussed in student theses, and published in scholarly journals, only group results will be presented and individual participants will not be identified.
All data files will be encrypted and storage disks will be password protected. Except when being transported, code-numbered paper data, saliva samples, and electronic data will be stored securely in a locked office at Acadia University.
Your child’s code number will be entered in the monthly prize draw and you will be contacted by phone or email if your child’s number is drawn.
16. Who is funding this study and are there any conflicts of interest?
Funding for this study comes from four different sources:
Mitacs – Accelerate grant (a government program to support graduate student training)
Acadia University Faculty Association research grant (Article 25.55)
Lallemand Health Solutions, Montreal, QC – Lallemand Health Solutions is providing the probiotics and placebo as well as financial support. Although they could benefit from the results should the study reveal any therapeutic effects of their encapsulated probiotics, the company is at arm’s length and is not involved in the data collection or analysis. While it is hoped that this research will provide further scientific evidence of the therapeutic potential of Lallemand’s Probio’Stick, they are equally open to the possibility that the results might not be in their favour.
Milk 2020 – this is a non-profit organization based in New Brunswick that is funded by dairy farmers and the government, aimed at developing and enhancing knowledge and innovation in order to support the growth of the dairy industry. Milk 2020 has provided financial support.
17. Are there other effective treatments available for treating ADHD and Anxiety Disorders in children?
Health Canada’s Good Clinical Practice Guidelines require us to discuss the potential benefits and drawbacks of other treatments that are available for your child’s condition.
ADHD: There are a variety of medications approved for the treatment of ADHD in children, and many children with ADHD are helped by these medications. The most commonly prescribed drugs for the treatment of ADHD are stimulants such as RitalinTM, ConcertaTM, and AdderallTM. These medications help many students by improving their attention and reducing their hyperactivity. Some children taking these medication experience unpleasant or undesirable side-effects such as insomnia, loss of appetite, and headaches, and they don’t work for everyone; approximately one third of children with ADHD do not respond well to treatment with stimulants. There is a non-stimulant medication approved for children with ADHD called StratteraTM that is effective for some children. Cognitive-behavioural therapy can help children cope with their ADHD and teach them strategies to help focus and sustain their attention and reduce their impulsivity, but children with ADHD typically continue to struggle. Consistency in effective parenting, routines, and expectations, along with good nutrition, exercise, and sleep may also be helpful.
Anxiety: There are currently no medications approved by Health Canada for the treatment of anxiety disorders in children under the age of 18. Selective Serotonin Reuptake Inhibitors (SSRIs) are commonly used to treat anxiety disorders in adults, but there are very few studies with children. The studies that do exist have yielded mixed results with most showing that SSRIs are not effective in children. Moreover, adverse emotional and behavioural reactions to SSRIs and other newer antidepressants can occur in children, including agitation, irritability and suicidal ideation. Another class of anti-anxiety medications known as benzodiazapenes (tranquilizers such as ValiumTM and AtivanTM) are often prescribed for adults, but these should not be given to children because they are highly addictive and can trigger anger and irritability in children. When a qualified and experienced child psychologist is available, psychotherapy, particularly behaviour therapy (and cognitive-behaviour therapy for older children) can often help children with anxiety problems. Psychotherapy is most successful when combined with positive lifestyle changes (good nutrition, sleep, and exercise) and effective, consistent parenting.
18. By participating in this study, will my child or I receive free counseling or psychotherapy for my child’s anxiety and/or ADHD?
Unfortunately, we are not able to provide our study participants with counseling or psychotherapy for a number of reasons. However, we would be happy to refer you or your child to a mental health professional if you felt you needed to see someone.
We recognize that it is possible that by answering questionnaires focusing on your child’s anxiety, ADHD, and/or physical ailments, you may feel upset as you reflect on these issues. If this should happen and you or your child find yourselves in need of counseling, please contact one of the following:
If you have a therapist, please contact him or her
The appropriate Mental Health Clinic at:
Mental Health, King’s County, Child & Youth Program (902) 679-2873
Valley Regional Hospital, Kentville (902) 679-2870
Annapolis Valley Health, Health Education (877) 365-1735
Hants Community Hospital, Windsor (902) 792-2042
Queen Elizabeth II Hospital, Halifax (902) 473-2043
Halifax Community Mental Health (902) 422-1611
If you would like a specific referral, please contact Dr. Susan Potter or Dr. Mark Johnston (contact information is at the top of this information sheet).
If you or your child are in need of urgent psychological help, please visit your nearest hospital emergency department.
19. Who should I contact if I have questions about the study or concerns about the research?
For enquiries about the research project, or specific questions about your child’s participation, please email email@example.com.
The project supervisor, Dr. Susan Potter, can be reached at firstname.lastname@example.org or (902) 585-1220.
For ethical concerns, please contact the Chair of the Acadia University Research Ethics Board, Dr. Stephen Maitzen, at email@example.com or (902) 585-1498.
This clinical trial has been approved by the Acadia University Research Ethics Board and Health Canada’s Natural Health Product Directorate.
to take our online screening questionnaire
to take our online screening questionnaire