Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa
- Conditions
- Microbiome DysbiosisAnorexia Nervosa
- Interventions
- Biological: Fecal Microbiome Transplant
- Registration Number
- NCT05834010
- Lead Sponsor
- Hvidovre University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMT Fecal Microbiome Transplant rectal or oral route FMT
- Primary Outcome Measures
Name Time Method Feasibility of FMT in AN patients 2 years The recruitment and compliance of 10-20 patients/year is feasible
Preferred route of FMT (questionnaire) 2 years FMT is offered as a Capsule-treatment orally or as an enema-rectally
- Secondary Outcome Measures
Name Time Method 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 measuring appetite related biomarkers: GLP-1
A single FMT treatment can alter GM composition in AN patients short term 2 yrs 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.
Trial Locations
- Locations (3)
Psychiatric Centre Ballerup
🇩🇰Ballerup, Denmark
Copenhagen University Hospital Hvidovre
🇩🇰Hvidovre, Denmark
Odense University Hospital
🇩🇰Odense, Denmark