Reestablishing Normal Gut-brain Interaction in Anorexia Nervose With Normal Gut Microbiota (Restart)

Reestablishing Normal Gut-Brain Interaction in Anorexia Nervosa With Normal Gut Microbiota: Restart

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Psychotherapy treatment as usual (TAU); Biological: Psychotherapy as usual combined with single dose normal gut microbiota

Detailed Description

Around fifty percent of the patients who enter psychotherapy for anorexia nervosa (AN) drop out from the psychotherapy. Nearly all patients who are unable to complete treatment have significant deterioration shortly after premature ending of psychotherapy. During the development of AN, the microbes in the gut are significantly altered probably due to malnutrition. Some studies indicate that these alterations in the composition of gut microbiota play a role in the maintenance of AN. In this study we are aiming at assessing the feasibility of combining psychotherapy with improvement of nutritional status with fecal microbiota transplantation (FMT). By improving the nutritional status of the patient before transplantation the transplant may have better survival with improved outcome. In this pilot study 36 patients who have at least one failed treatment attempt will be included. 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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Stein Frostad, MD PhD; Phone Number: +47 95003257; Email: stein.frostad@helse-bergen.no
• Study Contact Backup: Name: Olivia B Helland, Master of Science; Email: olivia.bysheim.helland@helse-bergen.no

Study Locations

• Norway
  • Haugesund
    • Haugesund, Haugesund, Norway, 5535
      • Haugalandet distriktspsykiatriske senter
      • Contact: Kenneth Eikeset, MD; Email: kenneth.eikeset@helse-fonna.no
  • Møre og Romsdal
    • Ålesund, Møre og Romsdal, Norway, 6026
      • Helse Møre og Romsdal
      • Contact: Dag AL Hoff, MD PhD; Email: Dag.Arne.Lihaug.Hoff@helse-mr.no
  • Norway
    • Bergen, Norway, Norway, 5096
      • Haukeland University Hospital in Helse Bergen
  • Sola
    • Stavanger, Sola, Norway, 4050
      • Sola distriktspsykiatriske senter
      • Contact: Øystein Enger, Specialist Clinical Psychology; Email: oystein.enger@sus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychotherapy treatment as usual (TAU); 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); Psychotherapy treatment as usual (TAU)
Experimental: Patients receiving TAU in combination with FMT; 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; Psychotherapy treatment as usual (TAU) combined with single dose normal fecal microbiota (FMT) will be compared with TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)	Body mass index to assess weight development	1 year
Eating disorder evaluation quesionnaire (EDE-Q) score	Global score of the EDE-Q score will be used to assess eating disorder symptom severity	1 year
Clinical impairment assessment questionnaire (CIA)	CIA will be used to assess the degree of influence on every life of the patient	1 year
ROME 4	The patients will be assessed for the presence of ROME 4 criteria for functional gastrointestinal disorders including irritable bowel syndrome	1 year
Irritable bowel syndrome symptome severity score (IBS-SSS)	IBS-SSS is used to assess the intensity of IBS symptoms	1 year
Gastrointestinal symptom rating scale for IBS (GSRS-IBS)	GSRS-IBS will be used to assess the gastrointestinal symptoms of IBS	1 year
Fecal microbiota composition	The composition of gut microbiota will be assessed when the patient has started psychotherapy and has estaliblished regular eating. In addition, composition of gut microbiota will be assessed one week after fecal microbiota transplantation	1 week

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: The Dam Foundation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Psychotherapy; Anorexia nervosa; Fecal microbiota transplantation
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Anorexia Nervosa; Behavioral Disciplines and Activities; Psychotherapy
• Other Study ID Numbers: 763219; SDAM_FORS509460 (Other Grant/Funding Number: Stiftelsen Dam)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Aggregated, deidentified data
• IPD Sharing Time Frame: November 1st 2028 and for five years thereafter
• IPD Sharing Access Criteria: Contact with principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No