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Fecal Microbiota Transplantation for ADHD

(FMT-ADHD-2026 Trial)

CE
AB
Overseen ByAsem Bala, BDS, MSc, CCRP, CCRA
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Calgary
Must be taking: Psychostimulants
Must not be taking: Antibiotics, Prebiotics
Disqualifiers: Substance use disorder, Suicidality, Anorexia, Tic disorders, others
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

TJ

Thomas J Raedler, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adolescents aged 13-17 with a confirmed diagnosis of ADHD who are already on stable medication. Participants must be able to communicate in English, have a consenting guardian, and meet certain symptom scores. Those with other major mental health or medical conditions, allergies to study drugs, or recent antibiotic/probiotic use cannot join.

Inclusion Criteria

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 baseline visit (V2)
Able to communicate and complete study assessments in English
Able to comply with all protocol procedures
See 4 more

Exclusion Criteria

I have been diagnosed with bipolar disorder.
I have been diagnosed with a tic disorder.
Participant has a score of ≥ 8 on oppositional defiant subset of SNAP-IV 26-Item Parent Rating Scale on day of screening (V1)
See 23 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antibiotic and Bowel Preparation

Participants receive a 6-day course of antibiotics or placebo, followed by bowel preparation the night prior to fecal microbiota transplantation

1 week
1 visit (in-person)

FMT or Placebo Administration

Participants receive oral FMT or placebo capsules (20 capsules daily for 3 consecutive days)

3 days
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and effectiveness of the treatment

24 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Fecal Microbiota Transplant (FMT)

Trial Overview

The study tests the safety and feasibility of oral Fecal Microbiota Transplantation (FMT) compared to placebo in teens with ADHD. Some participants may also receive antibiotics like Vancomycin or Nitazoxanide before FMT as part of the protocol.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3: Placebo antibiotics, bowel preparation, and FMT receivingExperimental Treatment4 Interventions
Group II: Arm 2: Antibiotic, bowel preparation, and placebo FMT receivingExperimental Treatment4 Interventions
Group III: Arm 1: Antibiotic, bowel preparation, and FMT receivingExperimental Treatment4 Interventions
Group IV: Arm 4: Placebo antibiotic, bowel preparation, and placebo FMT receivingPlacebo Group4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Hotchkiss Brain Institute, University of Calgary

Collaborator

Trials
12
Recruited
2,400+

Alberta Children's Hospital

Collaborator

Trials
58
Recruited
44,700+

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