Recruiting

FMT

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT07143981

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07143981

Start date

Jan 15, 2026

Status verified date

Jan, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Active treatment

Receiving FMT

Primary outcome measure

  • Feasibility of Intervention [ Time Frame: 1, 3, and 12 weeks post intervention ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Research Institute

Recruiting

London, Ontario, Canada, N6J 1A2

Contacts

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-01-23.