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

Sponsor
University of Calgary
Study ID
NCT07756255
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.
  • 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.
  • Placebo Vancomycin — DRUG
    Participants will receive a matching oral liquid vehicle placebo, administered twice daily for 6 consecutive days.
  • Placebo Nitazoxanide — DRUG
    Participants will receive matching oral placebo capsules, administered twice daily for 6 consecutive days.
  • 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.
  • 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.

Study Details

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).

Key Dates

First listed
Aug 10, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Antibiotic, bowel preparation, and FMT receiving
    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).
  • Experimental: Arm 2: Antibiotic, bowel preparation, and placebo FMT receiving
    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).
  • Experimental: Arm 3: Placebo antibiotics, bowel preparation, and FMT receiving
    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).
  • Placebo Comparator: Arm 4: Placebo antibiotic, bowel preparation, and placebo FMT receiving
    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).

Primary Outcome Measure

Feasibility: Number of Participants Enrolled [ Time Frame: 0-24 Weeks ]

Central Contacts

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