A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD

NCT07756255 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FMT-ADHD-2026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

ADHD; ADHD - Combined Type; ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

microbiome; microbiota transplants; fecal microbiota transplantation; gut microbiome therapy; gut microbiome; gut microbiota; neurodevelopmental disorders; neurodevelopment; ADHD; Attention Deficit Hyperactivity Disorder; gut brain axis; FMT; adolescent psychiatry; psychiatry; neuroscience

Outcome Measures

Primary Outcomes (9)

• Feasibility: Number of Participants Enrolled

  Feasibility of FMT in an Adolescent Population With ADHD will be determined by: Successful enrollment of at least 45 participants across the four trial arms

  0-24 Weeks

• Feasibility: Number of Participants Completing Study Protocol

  Feasibility of FMT in an Adolescent Population With ADHD will be determined by: A minimum of 45 participants to complete study until the 24-week primary endpoint

  0-24 weeks

• Feasibility: Number of Prescribed Capsule Doses Successfully Ingested

  Feasibility of FMT in an Adolescent Population With ADHD will be determined by adherence to study protocols: Receive at least 10/20 capsules per dosing visit

  0-24 weeks

• Feasibility: Number of Participants Completing Required Study Visits

  Feasibility of FMT in an Adolescent Population With ADHD will be determined by the adherence to study protocols: Attend all visits - attend the baseline visit (Visit 2- V2) and at least 2 follow up visits (V4-10).

  0-24 weeks

• Feasibility: Number of Participants Providing Required Biological Samples

  Feasibility of FMT in an Adolescent Population With ADHD will be determined by the adherence to study protocols: Provide biological samples at baseline visit (V2) and at least 2 follow up visits (V4-10)

  0-24 Weeks

• Safety: Number of Participants With Treatment-Emergent Adverse Events

  Safety of FMT in an Adolescent Population With ADHD will be determined by: Evaluating solicited and unsolicited adverse events, including serious adverse events

  0-24 weeks

• Safety: Change From Baseline in Suicidality Score on the Columbia-Suicide Severity Rating Scale (C-SSRS)

  Safety of FMT in an Adolescent Population With ADHD will be determined by: Monitoring suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS). The suicidal ideation subscale ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent), and the suicidal behavior subscale ranges from 0 (no behavior) to 5 (completed suicide). Higher scores indicate greater severity of suicidality.

  0-24 weeks

• Tolerability: Change From Baseline in Pittsburgh Side Effects Rating Scale (PSERS) Total Score

  Tolerability of FMT in Adolescents With ADHD will be determined by: Evaluating stimulant side effects using the Pittsburgh Side Effects Rating Scale (PSERS). Total scores range from 0 to 45 (or average score per item ranging from 0 to 3 across 15 symptoms: 0 = absent, 1 = mild, 2 = moderate, 3 = severe). Higher scores indicate greater severity of side effects.

  0-24 weeks

• Tolerability: Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score

  Tolerability of FMT in Adolescents With ADHD will be determined by: Evaluating gastrointestinal symptoms following colonic preparation and capsule dosing using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a 15-item questionnaire assessing GI symptoms across 5 domains (abdominal pain, reflux, indigestion, diarrhea, and constipation). Individual items are rated on a 7-point Likert scale ranging from 1 (no discomfort) to 7 (very severe discomfort), with total scores ranging from 15 to 105. Higher scores indicate greater GI symptom severity.

  0-24 weeks

Secondary Outcomes (5)

• Stool Samples - Microbiome Composition - Metagenomics: Change From Baseline in Gut Microbiome Alpha Diversity (Shannon Diversity Index) and Beta Diversity (Bray-Curtis Dissimilarity) via Shotgun Metagenomic Sequencing

  0-24 weeks

• Stool Samples - Microbiome Functional Activity - Metabolomics: Change From Baseline in Fecal Metabolite Concentrations Measured via Proton Nuclear Magnetic Resonance (1H-NMR) Spectroscopy

  0-24 weeks

• Saliva Samples - Oral Microbiome Composition - Metagenomics: Change From Baseline in Oral Microbiome Alpha Diversity (Shannon Diversity Index) and Beta Diversity (Bray-Curtis Dissimilarity) via Shotgun Metagenomic Sequencing

  0-24 weeks

• Saliva Samples - Oral Microbiome Composition - Metabolomic Analysis: Change From Baseline in Salivary Metabolite Concentrations Measured via Proton Nuclear Magnetic Resonance (1H-NMR) Spectroscopy

  0-24 weeks

• Blood Samples - Serum Inflammatory Cytokines: Change From Baseline in Serum Cytokine Concentrations

  0-24 weeks

Other Outcomes (3)

• ADHD Symptomology: Change From Baseline in the Swanson, Nolan, and Pelham Parent Rating Scale IV (SNAP-IV 26) Total Score

  0-24 weeks

• Functional Impairment: Change From Baseline in the Weiss Functional Impairment Rating Scale Self-Report (WFIRS-S) and Parent-Report (WFIRS-P) Total Score

  0-24 weeks

• Anxiety and Depression: Change From Baseline in the Revised Children's Anxiety and Depression Scale Self-Report (RCADS) and Parent Version (RCADS-P) Total Score

  0-24 weeks

Study Arms (4)

Arm 1: Antibiotic, bowel preparation, and FMT receiving

EXPERIMENTAL

Participants receive a 6-day course of antibiotics (nitazoxanide 500 mg BID and vancomycin 250 mg BID), followed by bowel preparation the night prior to fecal microbiota transplantation (FMT), and FMT oral capsules (20 capsules daily for 3 consecutive days).

Drug: Fecal Microbiota Transplant (FMT); Drug: Nitazoxanide 500mg BID; Drug: Vancomycin 250mg BID; Drug: Pico-Salax

Arm 2: Antibiotic, bowel preparation, and placebo FMT receiving

EXPERIMENTAL

Participants receive a 6-day course of antibiotic pretreatment (nitazoxanide 500 mg BID and vancomycin 250 mg BID), followed by bowel preparation the night prior to transplantation, and placebo FMT capsules (20 capsules daily for 3 consecutive days).

Drug: Nitazoxanide 500mg BID; Drug: Vancomycin 250mg BID; Drug: Pico-Salax; Drug: Placebo Fecal Microbiota Transplantation (FMT)

Arm 3: Placebo antibiotics, bowel preparation, and FMT receiving

EXPERIMENTAL

Participants receive a 6-day course of placebo antibiotic pretreatment (matching nitazoxanide and vancomycin BID), followed by bowel preparation the night prior to transplantation, and oral fecal microbiota transplantation (FMT) capsules (20 capsules daily for 3 consecutive days).

Drug: Fecal Microbiota Transplant (FMT); Drug: Placebo Vancomycin; Drug: Placebo Nitazoxanide; Drug: Pico-Salax

Arm 4: Placebo antibiotic, bowel preparation, and placebo FMT receiving

PLACEBO COMPARATOR

Participants receive a 6-day course of placebo antibiotic pretreatment (matching nitazoxanide and vancomycin BID), followed by bowel preparation the night prior to transplantation, and placebo FMT capsules (20 capsules daily for 3 consecutive days).

Drug: Placebo Vancomycin; Drug: Placebo Nitazoxanide; Drug: Pico-Salax; Drug: Placebo Fecal Microbiota Transplantation (FMT)

Interventions

Nitazoxanide 500mg BID DRUG

Participants will receive oral combination therapy consisting of Nitazoxanide (500 mg administered in capsule form) taken twice daily for 6 consecutive days, administered concurrently with oral liquid Vancomycin (250 mg) twice daily for 6 days prior to dosing.

Arm 1: Antibiotic, bowel preparation, and FMT receiving; Arm 2: Antibiotic, bowel preparation, and placebo FMT receiving

Vancomycin 250mg BID DRUG

Participants will receive oral liquid Vancomycin at a dose of 250 mg, administered twice daily for 6 consecutive days. This will be taken concurrently with oral Nitazoxanide capsules (500 mg) as part of FMT pre-treatment. Placebo antibiotic receiving participants will receive a matching oral liquid vehicle placebo on the identical twice-daily, 6-day schedule.

Arm 1: Antibiotic, bowel preparation, and FMT receiving; Arm 2: Antibiotic, bowel preparation, and placebo FMT receiving

Placebo Vancomycin DRUG

Participants will receive a matching oral liquid vehicle placebo, administered twice daily for 6 consecutive days.

Arm 3: Placebo antibiotics, bowel preparation, and FMT receiving; Arm 4: Placebo antibiotic, bowel preparation, and placebo FMT receiving

Placebo Nitazoxanide DRUG

Participants will receive matching oral placebo capsules, administered twice daily for 6 consecutive days.

Arm 3: Placebo antibiotics, bowel preparation, and FMT receiving; Arm 4: Placebo antibiotic, bowel preparation, and placebo FMT receiving

Pico-Salax DRUG

Participants will undergo bowel cleansing prior to the intervention. On the evening before the first day of dosing participants will consume 1.5 sachets of Pico-Salax mixed in water, followed by eight 250 mL glasses of water over the subsequent 60 minutes to induce a bowel purge over an expected 6- to 8-hour period.

Arm 1: Antibiotic, bowel preparation, and FMT receiving; Arm 2: Antibiotic, bowel preparation, and placebo FMT receiving; Arm 3: Placebo antibiotics, bowel preparation, and FMT receiving; Arm 4: Placebo antibiotic, bowel preparation, and placebo FMT receiving

Fecal Microbiota Transplant (FMT) DRUG

Participants will receive active oral FMT capsules, administered over three consecutive visits with each dose spaced 24 hours apart (20 capsules per visit at Visits 3A, 3B, and 3C). This will be administered following bowel preparation to serve as the primary therapeutic intervention for the active FMT regimen.

Arm 1: Antibiotic, bowel preparation, and FMT receiving; Arm 3: Placebo antibiotics, bowel preparation, and FMT receiving

Placebo Fecal Microbiota Transplantation (FMT) DRUG

Participants will receive matching oral placebo capsules, administered over three consecutive visits with each dose spaced 24 hours apart (20 capsules per visit at Visits 3A, 3B, and 3C). This will be administered following bowel preparation to serve as the control comparator for the active FMT regimen.

Arm 2: Antibiotic, bowel preparation, and placebo FMT receiving; Arm 4: Placebo antibiotic, bowel preparation, and placebo FMT receiving

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• a. First line pharmacotherapy treatment will be defined based on the CADDRA guidelines \[63\] and include the following
• Amphetamine-based psychostimulants:
• i. Mixed amphetamine salts (amphetamine and dextroamphetamine) ii. Lisdexamfetamine dimesylate
• Methylphenidate-based psychostimulants:
• i. Methylphenidate hydrochloride, Methylphenidate hydrochloride (extended release, multilayer release capsules) ii. Methylphenidate hydrochloride (extended release, OROS tablets) iii. Methylphenidate hydrochloride (controlled release, multi-layer beat capsules) iv. Methylphenidate hydrochloride (extended-release oral suspension)
• 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.
• Consenting guardian

You may not qualify if:

• 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
• Bipolar Disorder
• Conduct Disorder
• Participant has a score of ≥ 8 on the oppositional defiant subset of the SNAP-IV 26-Item Parent Rating Scale (questions 19-26) on the day of screening (V1).
• Intellectual or learning disability based on previous documented diagnosis or clinical judgment of Principal Investigator.
• Documented diagnosis of Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) or Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS).
• Documented diagnosis of schizophrenia or schizoaffective disorder.
• Documented diagnosis of Autism Spectrum Disorder (ASD) or currently undergoing assessment for suspected ASD.

Sponsors & Collaborators

• University of Calgary: lead
• Hotchkiss Brain Institute, University of Calgary: collaborator
• Alberta Children's Hospital: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2M 1R5, Canada

Location

Related Publications (19)

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Related Links

• The Taylor Lab Website

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders

Interventions

Fecal Microbiota Transplantation; nitazoxanide; BID protein, human; Vancomycin; Pico-Salax

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas J Raedler, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cleo E Hendrickson, BSc

CONTACT

4032106495; FMT.ADHD@ucalgary.ca

Asem Bala, BDS, MSc, CCRP, CCRA

CONTACT

403-210-7282; asem.bala@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Phase 1 (Interventional - Weeks 0-24): Double-blind phase. Participants, care providers, investigators, and outcomes assessors are fully blinded to the 1:1:1:1 allocation (active/placebo antibiotics and active/placebo FMT). Phase 2 (Observational - Optional long term follow up - Weeks 24-48+): Single blind phase. Staff and investigators are unblinded for primary analysis and safety monitoring. Participants and their study partners remain blinded through the optional long-term follow-up to minimize bias. Due to outcomes rely on self- and parent-administered questionnaires, staff unblinding is not expected to affect data integrity. Individually sealed allocation envelopes and master codes are maintained securely by the FMT capsule manufacturer - The University of Calgary Infection Prevention \& Control Research Laboratories. Only the unblinded lab technician preparing the interventions has access to these files.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-phase, randomized, placebo-controlled, factorial-design trial evaluating the feasibility, safety, and tolerability of Fecal Microbiota Transplantation (FMT) in 64 adolescents with ADHD on stable first-line pharmacological treatment. Phase 1 (Double-Blinded Interventional): Participants are randomized 1:1:1:1 into four parallel groups (n=16 per group) to evaluate the individual and combined impact of the interventions: Group 1 (Active Antibiotics + Bowel Prep + Active FMT), Group 2 (Active Antibiotics + Bowel Prep + Placebo FMT), Group 3 (Placebo Antibiotics + Bowel Prep + Active FMT), and Group 4 (Placebo Antibiotics + Bowel Prep + Placebo FMT). Phase 2 (Single-Blinded Observational): Following the interventional period, participants transition into a single-blinded observational phase to monitor long-term safety, tolerability, and maintenance of outcomes

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

CA (1)