Clinical trial NCT05834010: Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa
Official title: Feasibility Study of Using Fecal Microbiota Transplants (FMT) in Supportive Treatment of Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Anorexia Nervosa
Microbiome Dysbiosis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Odense University Hospital
name: Psychiatric Center Ballerup
First posted: 2023-04-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1 single FMT event either oral route or rectal. Sampling fecal matter and blood at baseline and 1 week after FMT.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of FMT in AN patients
timeFrame: 2 years
measure: Preferred route of FMT (questionnaire)
timeFrame: 2 years
Secondary outcomes:
measure: A single FMT treatment can alter GM composition in AN patients short term
timeFrame: 2 yrs
measure: 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
timeFrame: 2 yrs
measure: 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
timeFrame: 2 yrs
measure: 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
timeFrame: 2 yrs
measure: 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
timeFrame: 2 yrs
measure: 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
timeFrame: 2 yrs
measure: 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
timeFrame: 2 yrs
Other outcomes:
measure: FMT questionnaires
timeFrame: 2 yrs
Locations:
city: Ballerup
country: Denmark
facility: Psychiatric Centre Ballerup
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References: