Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa (ReBoot)
Primary Purpose
Anorexia Nervosa, Microbiome Dysbiosis
Status
Recruiting
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Fecal Microbiome Transplant
Sponsored by
About this trial
This is an interventional basic science trial for Anorexia Nervosa
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
Sites / Locations
- Psychiatric Centre BallerupRecruiting
- Copenhagen University Hospital HvidovreRecruiting
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FMT
Arm Description
rectal or oral route FMT
Outcomes
Primary Outcome Measures
Feasibility of FMT in AN patients
The recruitment and compliance of 10-20 patients/year is feasible
Preferred route of FMT (questionnaire)
FMT is offered as a Capsule-treatment orally or as an enema-rectally
Secondary Outcome Measures
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.
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
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
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,
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
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
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
Full Information
NCT ID
NCT05834010
First Posted
March 18, 2023
Last Updated
April 18, 2023
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen, Odense University Hospital, Psychiatric Center Ballerup
1. Study Identification
Unique Protocol Identification Number
NCT05834010
Brief Title
Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa
Acronym
ReBoot
Official Title
Feasibility Study of Using Fecal Microbiota Transplants (FMT) in Supportive Treatment of Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen, Odense University Hospital, Psychiatric Center Ballerup
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Microbiome Dysbiosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
1 single FMT event either oral route or rectal. Sampling fecal matter and blood at baseline and 1 week after FMT.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FMT
Arm Type
Experimental
Arm Description
rectal or oral route FMT
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiome Transplant
Other Intervention Name(s)
Fecal Matter Transplant
Intervention Description
Fecal matter from healthy age/sex matched established and screened donors, recruited from the Danish Blood-donor system
Primary Outcome Measure Information:
Title
Feasibility of FMT in AN patients
Description
The recruitment and compliance of 10-20 patients/year is feasible
Time Frame
2 years
Title
Preferred route of FMT (questionnaire)
Description
FMT is offered as a Capsule-treatment orally or as an enema-rectally
Time Frame
2 years
Secondary Outcome Measure Information:
Title
A single FMT treatment can alter GM composition in AN patients short term
Description
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.
Time Frame
2 yrs
Title
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
Description
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
Time Frame
2 yrs
Title
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
Description
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
Time Frame
2 yrs
Title
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
Description
measuring appetite related biomarkers: Ghrelin,
Time Frame
2 yrs
Title
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
Description
measuring appetite related biomarkers: Insulin
Time Frame
2 yrs
Title
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
Description
measuring appetite related biomarkers: Glucagon
Time Frame
2 yrs
Title
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
Description
measuring appetite related biomarkers: GLP-1
Time Frame
2 yrs
Other Pre-specified Outcome Measures:
Title
FMT questionnaires
Description
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.
Time Frame
2 yrs
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kenneth K barfod, phd cand.scient.bio
Phone
+45 60777016
Email
kenneth.barfod@food.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
andreas M petersen, MD Phd Dr.
Phone
+45 38626199
Email
Andreas.Munk.Petersen@regionh.dk
Facility Information:
Facility Name
Psychiatric Centre Ballerup
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Miscali, MD PhD
Email
nadia.micali@regionh.dk
First Name & Middle Initial & Last Name & Degree
Thea S Lokind, nurse
Email
thea.stine.lokind@regionh.dk
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
andreas m petersen, MD
Phone
+4538625960
First Name & Middle Initial & Last Name & Degree
Ida M Grønbæk, MD
Phone
+4538623862
First Name & Middle Initial & Last Name & Degree
Kenneth Barfod, PhD
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René K Støvring, md Phd
Phone
+45 40884486
Email
rene.stoeving@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa
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