Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota
Starting soon · Phase 1
Conditions studied: Anorexia Nervosa
In brief
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.
Key facts
- Study ID
- NCT07574892
- Run by
- Haukeland University Hospital
- People needed
- 36
- Starts
- 2026-06-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or more Starting outpatient psychotherapy for anorexia nervosa At least one failed qualified treatment attempt
You may not qualify if…
- 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.
Where it is running
- Haugalandet distriktspsykiatriske senter — Haugesund, Haugesund, Norway
- Helse Møre og Romsdal — Ålesund, Møre og Romsdal, Norway
- Haukeland University Hospital in Helse Bergen — Bergen, Norway, Norway
- Sola distriktspsykiatriske senter — Stavanger, Sola, Norway
Full record on ClinicalTrials.gov
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