Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa

NCT05834010 | Completed Early Phase 1 DMC

• 1 other identifier: H-22030034
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators hypothesize that prolonged undernutrition in anorexia nervosa alters the microbiome to a different steady-state (dysbiotic) composition that sustains the disease, even after returning to normal diet. The investigators propose that transplanting a fully ecologically functioning GM from a healthy donor, through a FMT, can reboot the gut-brain-axis, ameliorate symptoms and improve clinical outcomes. To approach this, in the challenging AN patient group, the investigators want to conduct a FMT feasibility/pilot study.

Conditions

Anorexia Nervosa; Microbiome Dysbiosis

Outcome Measures

Primary Outcomes (2)

• Feasibility of FMT in AN patients

  The recruitment and compliance of 10-20 patients/year is feasible

  2 years

• Preferred route of FMT (questionnaire)

  FMT is offered as a Capsule-treatment orally or as an enema-rectally

  2 years

Secondary Outcomes (7)

• A single FMT treatment can alter GM composition in AN patients short term

  2 yrs

• A single FMT treatment can alter gut brain signaling in serum. might changes serum signal molecules related to appetite and metabolism with in same patien

  2 yrs

• A single FMT treatment can alter gut brain signaling in serum. might changes serum signal molecules related to appetite and metabolism with in same patien

  2 yrs

• A single FMT treatment can alter gut brain signaling in serum. might changes serum signal molecules related to appetite and metabolism with in same patien

  2 yrs

• A single FMT treatment can alter gut brain signaling in serum. might changes serum signal molecules related to appetite and metabolism with in same patien

  2 yrs

Other Outcomes (1)

• FMT questionnaires

  2 yrs

Study Arms (1)

FMT

EXPERIMENTAL

rectal or oral route FMT

Biological: Fecal Microbiome Transplant

Interventions

Fecal Microbiome Transplant BIOLOGICAL

Fecal matter from healthy age/sex matched established and screened donors, recruited from the Danish Blood-donor system

Also known as: Fecal Matter Transplant

FMT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age \<18 years. Known ongoing abuse of laxatives.
• Antibiotic treatment within the last three months.
• Probiotics within the last month
• Inflammatory bowel disease, colorectal cancer or other known chronic bowel disorder

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator
• Odense University Hospital: collaborator
• Psychiatric Center Ballerup: collaborator

Study Sites (3)

Psychiatric Centre Ballerup

Ballerup Municipality, Denmark, 2750, Denmark

Location

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• 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. doi: 10.1038/s41467-026-68455-8. Online ahead of print.

  PMID: 41535289 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. MD pHD Clinical Associate Research Professor

Model Details: 1 single FMT event either oral route or rectal. Sampling fecal matter and blood at baseline and 1 week after FMT.

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: April 27, 2023
• Study Start: March 18, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)