The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa

NCT07143981 | Recruiting

• 1 other identifier: ANFMT-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Anorexia Nervosa (AN) is a severe, debilitating and potentially life threatening illness that is difficult to treat. A cardinal symptom of AN is the mistaken belief on the part of the individuals that they are overweight and must continue to restrict intake. This fixed false belief is a detrimental factor to recovery. It is known that AN involves disturbance in the gut microbiome (GM; the microbes that live in the lower intestinal tract). The GM also affects how one thinks and makes food choices - there appears to be a direct link between the GM and how the brain functions. This connection is thought to occur through chemical processes that convey information from the gut to the brain. It is known that fecal microbiome transplant (FMT) has been useful in treating several illnesses, including several mental illnesses. The investigators intend to deliver FMT to individuals with AN to determine the extent to which this modifies their GM, their biochemistry, their thinking processes and their moods and emotions. The investigators believe this will illuminate important aspects of AN that keep the illness in place, and that this will uncover useful approaches to better treat it.

Conditions

Anorexia Nervosa

Keywords

Microbiome; Fecal transplant; Gut microbiome; Gut brain axis; Mental health; Eating Disorders

Outcome Measures

Primary Outcomes (1)

• Feasibility of Intervention

  Success will be evaluated using recruitment and retention rates, adverse event rates, and missing data rates. Scores at 75% or above will indicate high tolerability for this population that is in desperate need of additional intervention options.

  1, 3, and 12 weeks post intervention

Secondary Outcomes (12)

• Shannon's Diversity Index

  Pre-intervention, 12 weeks post-intervention

• Activated blood cells producing Th17/Th2 cytokines

  Pre-intervention, and 12-weeks post intervention

• Activated blood cells producing BDNF

  Pre-intervention and 12-weeks post-intervention

• RNA levels

  Pre-intervention and 12-weeks post-intervention

• Task-switching Efficiency

  Pre-intervention, and 12 weeks post-intervention

Study Arms (1)

Active treatment

Receiving FMT

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will be awaiting treatment for anorexia nervosa at London Health Sciences Centre's (LHSC, Ontario Canada) Adult Eating Disorders Service (AEDS).

You may qualify if:

• meet DSM 5 criteria for AN, restricting type, moderate or higher severity, as indicated by a BMI\<17
• Participants must we willing and able to swallow FMT capsules without vomiting
• Able to read and understand conversational English

You may not qualify if:

• Medical or psychiatric instability needing hospitalization
• Patients with AN binge/purge type
• Use of antibiotics or probiotics in the month prior to treatment
• Regular oral steroid use, or potent topical steroid use on large sections of skin
• Chronic immune compromise and chronic illness affecting the intestinal tract or metabolic health
• Pregnancy or intended pregnancy over the time of study
• Patients enrolled in any treatment program that involves refeeding

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator

Study Sites (1)

London Health Sciences Research Institute

London, Ontario, N6J 1A2, Canada

RECRUITING

Related Links

• Provides theoretical support for this project
• Provides theoretical support for this project

MeSH Terms

Conditions

Anorexia Nervosa; Psychological Well-Being; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Osuch

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Wammes

CONTACT

519-646-6000; michael.wammes@lhsc.on.ca

Medina Meddaoui

CONTACT

medina.meddaoui@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: August 27, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)