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

NCT07574892 | Not Yet Recruiting Phase 1

• 2 other identifiers: 763219SDAM_FORS509460
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa; Fecal microbiota transplantation; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of performing treatment with psychotherapy as usual (TAU) in combination with a single dose of fecal microbiota transplantation

  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.

  1 year

Secondary Outcomes (7)

• Body mass index (BMI)

  1 year

• Eating disorder evaluation quesionnaire (EDE-Q) score

  1 year

• Clinical impairment assessment questionnaire (CIA)

  1 year

• ROME 4

  1 year

• Irritable bowel syndrome symptome severity score (IBS-SSS)

  1 year

Study Arms (2)

Psychotherapy treatment as usual (TAU)

ACTIVE COMPARATOR

The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU)

Other: Psychotherapy treatment as usual (TAU)

Patients receiving TAU in combination with FMT

EXPERIMENTAL

The 18 patient with anorexia nervosa randomized to this arm will receive treatment with psychotherapy for anorexia nervosa as usual (TAU) in combination with a single dose fecal microbiota transplantation (FMT)

Biological: Psychotherapy as usual combined with single dose normal gut microbiota

Interventions

Psychotherapy as usual combined with single dose normal gut microbiota BIOLOGICAL

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

Patients receiving TAU in combination with FMT

Psychotherapy treatment as usual (TAU) OTHER

Psychotherapy treatment as usual (TAU)

Psychotherapy treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• The Dam Foundation: collaborator

Study Sites (4)

Haugalandet distriktspsykiatriske senter

Haugesund, Haugesund, 5535, Norway

Location

Helse Møre og Romsdal

Ålesund, Møre og Romsdal, 6026, Norway

Location

Haukeland University Hospital in Helse Bergen

Bergen, Norway, 5096, Norway

Location

Sola distriktspsykiatriske senter

Stavanger, Sola, 4050, Norway

Location

Related Publications (2)

• Panah FM, Stoving RK, Sjogren M, Micali N, Maschek S, Reis KD, Mirsepasi-Lauridsen HC, Petersen AM, Nielsen DS, Helms M, Rasmussen MA, Barfod KK. Impact of a single fecal microbiome transplantation in adult women with anorexia nervosa: an open-label feasibility pilot trial. Nat Commun. 2026 Jan 14;17(1):1747. doi: 10.1038/s41467-026-68455-8.

  PMID: 41535289 BACKGROUND

• Frostad S. Are the Effects of Malnutrition on the Gut Microbiota-Brain Axis the Core Pathologies of Anorexia Nervosa? Microorganisms. 2022 Jul 24;10(8):1486. doi: 10.3390/microorganisms10081486.

  PMID: 35893544 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Stein Frostad, MD PhD

CONTACT

+47 95003257; stein.frostad@helse-bergen.no

Olivia B Helland, Master of Science

CONTACT

olivia.bysheim.helland@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to two separat groups which will receive either psychotherapy treatment as usual (TAU) in combination with fecal microbiota transplantation or TAU alone

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: November 1st 2028 and for five years thereafter
• Access Criteria: Contact with principal investigator

Locations

NO (4)