A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD (NCT07756255) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD
Canada64 participantsStarted 2026-08-31
Plain-language summary
The primary goals of this phase 2 clinical trial are to determine the feasibility, safety, and tolerability of oral Fecal Microbiota Transplantation (FMT) in adolescents (aged 13-17) with Attention-Deficit/Hyperactivity Disorder (ADHD).
Who can participate
Age range
13 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between 13-17 years of age with consent of a legal guardian: Participants should be at least 13 years old and not older than 17 years at the day of screening (V1).
. Have a primary diagnosis of ADHD as confirmed by the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
. Be on a stable appropriate dose of an appropriate first-line pharmacological treatment for at least 8 weeks prior to the day of screening (V1).
. Have a score of ≥ 18 on the inattention subset (questions 1-9) and/or the hyperactivity/impulsivity subset (questions 10-18) of the SNAP-IV 26-Item Parent Rating Scale on the day of screening (V1) and the baseline visit (V2).
. Able to communicate and complete study assessments in English.
. Able to comply with all protocol procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: Number of Participants Enrolled
Timeframe: 0-24 Weeks
2
Feasibility: Number of Participants Completing Study Protocol
Timeframe: 0-24 weeks
3
Feasibility: Number of Prescribed Capsule Doses Successfully Ingested
Timeframe: 0-24 weeks
4
Feasibility: Number of Participants Completing Required Study Visits
Timeframe: 0-24 weeks
5
Feasibility: Number of Participants Providing Required Biological Samples
Timeframe: 0-24 Weeks
6
Safety: Number of Participants With Treatment-Emergent Adverse Events
Timeframe: 0-24 weeks
7
Safety: Change From Baseline in Suicidality Score on the Columbia-Suicide Severity Rating Scale (C-SSRS)
. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Criteria for the following conditions according to the MINI-KID:
. Diagnosis of a Substance Use Disorder within the last 3 months prior to screening. \*(Criteria should include Alcohol and Non-Alcohol substances except Cannabis)
. Moderate or severe Substance Use Disorder for Cannabis use in the last 3 months
. Currently active high suicidality. Eligibility of Participants who meet criteria for moderate suicidality is determined by clinical judgment of Principal Investigator.
. Active Anorexia Nervosa or Bulimia Nervosa in the last 3 months.
. Tic Disorders
. Psychosis
. Obsessive Compulsive Disorder
Tolerability: Change From Baseline in Pittsburgh Side Effects Rating Scale (PSERS) Total Score
Timeframe: 0-24 weeks
9
Tolerability: Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score