Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota

NCT07574892 · tracked via the Priya Life Science Norway tracker

Sponsor

Haukeland University Hospital

Phase

Phase 1

Started

2026-12-01

Last updated

2026-09-24

Condition(s) studied

Anorexia Nervosa

Investigational drug(s) / intervention(s)

Psychotherapy as usual combined with single dose normal gut microbiotaPsychotherapy treatment as usual (TAU)

Psychotherapy as usual combined with single dose normal gut microbiota: Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU

Psychotherapy treatment as usual (TAU): Psychotherapy treatment as usual (TAU)

Study summary

In this pilot study 36 patients with anorexia nervosa (AN) will be randomized to either treatment with psychotherapy as usual (TAU) or TAU plus fecal microbiota transplantation (FMT). The transplantation will be performed when refeeding has started. Patients randomized to TAU+FMT will choose either capsules or gastroscopy as source of FMT. One week after FMT gut microbiota will be collected and analyzed and compared with microbiota composition at baseline. The two groups are then followed during psychotherapy to assess whether it is feasible to give FMT during psychotherapy to study the effects on outcome. In addition, this pilot study is aiming at paving the way for performing larger studies to assess whether FMT improves outcome from psychotherapy when given in combination with psychotherapy in patients with AN.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Age 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt Exclusion Criteria: Age below 18 years BMI below 16 kg/m2 Significant electrolyte disturbances Other signs of medical instability Presence of systemic disease, Immune deficiency Treated with immune-modulating medication Pregnancy Planning pregnancy Lactations Having undergone abdominal surgery (with the exception of appendectomy, cholecystectomy, caesarian section and hysterectomy) severe psychiatric disease (except anorexia nervosa) Use of probiotics or treatment with antibiotics within 8 weeks prior to study entry.

Primary outcome measure(s)

Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation — 1 year
A single dose of fecal microbiota transplantation will be administered when the patients has established a nutritional status allowing survival of the transplant. Then the patients will be followed to the end of psychotherapy. Assessments will include description of gut microbiota composition and questionnaires describing the clinical course of the eating disorder.

Trial sites (4)

Facility	City	Region
Haugalandet distriktspsykiatriske senter	Haugesund	Haugesund
Helse Møre og Romsdal	Ålesund	Møre og Romsdal
Haukeland University Hospital in Helse Bergen	Bergen	Norway
Sola distriktspsykiatriske senter	Stavanger	Sola

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Other trials for the same condition

Effectiveness Trial of Temperament Based Therapy With Support (TBT-S) Recruiting

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Cognitive Training for Patients With Eating Disorders Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07574892 on ClinicalTrials.gov ↗ ← All trials in Norway