Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa (ReBoot)

Feasibility Study of Using Fecal Microbiota Transplants (FMT) in Supportive Treatment of Anorexia Nervosa

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa; Microbiome Dysbiosis
• Intervention / Treatment: Biological: Fecal Microbiome Transplant

Detailed Description

Anorexia nervosa (AN) still carries the highest fatality rate of any psychiatric disease, and less than half of the patients recover, completely refractory to any treatment. The etiology remains unknown and evidence for treatment is lacking. We have an established collaboration bridging several disciplines and people in medicine, bioinformatics and biology with a focus on the pathological role of gut microbiome in the psychiatric disorder Anorexia nervosa. The GM in healthy people has been shown to affect weight gain, appetite and behavior through the gut-brain axis. We hypothesize that prolonged undernutrition in AN alters the microbiome to a different steady-state (dysbiotic) composition that sustains the disease, even after returning to normal diet. AN patients enter voluntarily into programs of therapeutic weight gain and reintroduction to normal food intake. 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, we want to conduct a FMT feasibility/pilot study. The investigators want approach the FMT intervention, with 20 AN patients in sequence before any attempt at more complex blinded /placebo clinical trials. The investigators will collect GM samples and clinical data from these patients and describe the altered composition and diversity of the AN-GM and how it changes with FMT.

Ultimately, the investigators aim to provide evidence that GM modulation with FMT can ameliorateclinical outcomes of AN. The investigators will investigate the feasibility of using FMT in supportive treatment of AN and by identifying specific bacterial and viral changes with FMT, we will lay the groundwork for randomized placebo-controlledstudies, to develop new GM interventions to complement current treatment of AN.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Ballerup, Denmark, 2750
    • Psychiatric Centre Ballerup
  • Hvidovre, Denmark, 2650
    • Copenhagen University Hospital Hvidovre
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion: Women referred to the participating specialized centers or by advertising who fulfill the of a diagnosis of Anorexia Nervosa according to the criteria as specified in the Diagnostic and Statistical Manual of Mental Disorders(DSM) version 5.

Exclusion:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT; rectal or oral route FMT	Biological: Fecal Microbiome Transplant; Fecal matter from healthy age/sex matched established and screened donors, recruited from the Danish Blood-donor system; Other Names: Fecal Matter Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A single FMT treatment can alter GM composition in AN patients short term	16S rRNA gene sequencing: Outcome: we expect GM to normalize towards the donor GM composition e.g higher diversity and composition of species, within the single patient and also compared to both healthy(NO-FMT) and AN(NO-FMT) controls.	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	measuring appetite related biomarkers: PYY might changes serum signal molecules related to appetite and metabolism with in same patient comparison, before and 1 week after FMT in a direction for higher appetite	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	measuring appetite related biomarkers: Leptin might changes serum signal molecules related to appetite and metabolism with in same patient comparison, before and 1 week after FMT in a direction for higher appetite	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	measuring appetite related biomarkers: Ghrelin,	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	measuring appetite related biomarkers: Insulin	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	measuring appetite related biomarkers: Glucagon	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	measuring appetite related biomarkers: GLP-1	2 yrs

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMT questionnaires	With regards to the Pre and post FMT questionnaires we expect only to obtain patient narratives and guidance towards future designs since this is a feasibility study. We also hope to catch small self reported changes to "gut-feeling" in a positive direction. It is plausible that just one FMT might significantly lower discomfort as a result of changes to GM signaling. Again this serves only as a fesibility of using this type of questions in a future larger trial.	2 yrs

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Odense University Hospital; University of Copenhagen; Psychiatric Center Ballerup

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2023
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Dysbiosis; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: H-22030034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No