Fecal Microbiota Transplant for Anorexia Nervosa

Sponsor
Hamilton Health Sciences Corporation
Study ID
NCT06593366
Status
Not Yet Recruiting

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Conditions

  • Anorexia
  • Anorexia Nervosa
  • Anorexia Nervosa Restricting Type
  • Anorexia in Adolescence
  • Anorexia in Children

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplant — BIOLOGICAL
    An investigational biologic comprised of 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule, to be taken twice per day, twice per week over an 8-week duration.
  • Placebo — DRUG
    Oral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration.

Study Details

The purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among patients with anorexia nervosa (AN). Specifically, the investigators aim to compare changes in weight, gut microbiome, urine, blood biomarkers and mood symptoms between participants receiving the FMT intervention and placebo.

Key Dates

First listed
Sep 19, 2024
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Fecal Microbiota Transplant
    Banked donor stools that have been previously screened, prepared and frozen per previous protocols will be used to prepare all oral FMT capsules (OFC) through the laboratory of a collaborator. Recipients will receive OFC (two capsules, twice a day, twice per week) prepared from a single donor throughout their 8-week treatment course, to support assessment of FMT engraftment in recipients; this totals to 64 capsules across the duration of the study. Each OFC will contain approximately 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule.
  • Placebo Comparator: Placebo
    Matching oral placebo capsules (OPC) containing methylcellulose will be identical in terms of size, colour, taste, and dosing. Participants will be asked to take the Placebo treatment capsules twice a day for two days per week for a duration of eight weeks (total 64 capsules).

Primary Outcome Measure

Recruitment Rate [ Time Frame: Through study completion, an average of one year. ]

Central Contacts

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