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Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa

NCT05834010 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-06-27

No results posted yet for this study

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

Interventions

BIOLOGICAL

Fecal Microbiome Transplant

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

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Psychiatric Center Ballerup

    collaborator OTHER

  • Hvidovre University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-18
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05834010 on ClinicalTrials.gov