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

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 - Attention Deficit Disorder With Hyperactivity
• ADHD - Combined Type

Interventions

DRUG

Fecal Microbiota Transplant (FMT)

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.

DRUG

Nitazoxanide 500mg BID

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.

DRUG

Vancomycin 250mg BID

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.

DRUG

Placebo Vancomycin

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

DRUG

Placebo Nitazoxanide

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

DRUG

Pico-Salax

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.

DRUG

Placebo Fecal Microbiota Transplantation (FMT)

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.

Sponsors & Collaborators

• Hotchkiss Brain Institute, University of Calgary

  collaborator OTHER

• Alberta Children's Hospital

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Thomas J Raedler, MD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

13 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2028-08-31

Completion

2029-08-31

Countries

• Canada

Study Locations