Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— ReBoot  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834010
• Other study ID #: H-22030034
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 18, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: April 2023
• Source: Hvidovre University Hospital
• Contact: kenneth K barfod, phd cand.scient.bio
• Phone: +45 60777016
• Email: kenneth.barfod[@]food.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Dysbiosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Psychiatric Centre Ballerup	Ballerup
Denmark	Copenhagen University Hospital Hvidovre	Hvidovre
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Odense University Hospital, Psychiatric Center Ballerup, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Feasibility of FMT in AN patients	The recruitment and compliance of 10-20 patients/year is feasible	2 years
Primary	Preferred route of FMT (questionnaire)	FMT is offered as a Capsule-treatment orally or as an enema-rectally	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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