Clinical trial NCT06593366: Fecal Microbiota Transplant for Anorexia Nervosa
Official title: A Pilot Feasibility Randomized Controlled Trial of Fecal Microbiota Transplant for Adolescent Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa Restricting Type
Anorexia Nervosa
Anorexia in Adolescence
Anorexia in Children
Anorexia
Keywords: anorexia nervosa
fecal microbiota transplant
pilot study
randomized controlled trial
feasibility
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among patients with anorexia nervosa (AN). Specifically, the investigators aim to compare changes in weight, gut microbiome, urine, blood biomarkers and mood symptoms between participants receiving the FMT intervention and placebo.

Detailed description: In the following pilot randomized-controlled trial, the investigators' aim is to determine whether FMT treatment demonstrates feasibility, acceptability, and preliminary effectiveness in pediatric AN participants. The investigators will assess how the use of FMT affects participants' rate of weight restoration, gut microbiome, relevant urine and blood biomarkers, and mood symptoms. The investigators' rationale for performing the study is to better understand the interactions between the intestinal microbiome, energy regulation, and behavior. This will be the first study to assess the role of FMT in pediatric AN and will help establish whether this adjunctive treatment modality has benefit in managing the metabolic and behavioral manifestations of this complex neuropsychiatric disorder.

In terms of study procedures, members of a pilot sample of 20 AN patients recruited from McMaster Children's Hospital will be randomized to receive FMT or placebo. All participants will be asked to complete a battery of assessments at regular intervals over the 8-week intervention period, and at a follow-up point at four weeks post-intervention.

The study's primary outcomes are recruitment and retention rates. Descriptive statistics will be used to determine the number of adolescents who will agree to participate in the study and those who will complete the study.

One of the study's secondary outcomes is participants' attitudes toward FMT. This will be measured through qualitative interviews among those who completed the intervention and those who do not agree to participate in the study.

The investigators will know we have reached saturation by using a method called "information power" and will explore how broad the research questions are, if there are clear theories to guide the analysis, how varied the participants in the study are, and how much useful information is accrued. Based on this, the investigators will determine the appropriate number of interviews to lead.

The remaining secondary outcome is a battery of preliminary outcomes (clinical, biological, biochemical and safety). The investigators will assess these outcomes at multiple timepoints using questionnaires, anthropometric data, stool analysis (16s rRNA), urine metabolic analysis, saliva ultra filtrates, changes in blood work, and common terminology criteria for adverse events for safety outcomes.

Eligibility criteria: Inclusion Criteria: All study subjects will have been diagnosed with AN (restricting type or binge eating/purging type) by the primary physician on the ED team, as per standard approach. Study participants will:

* Be 12-17 years-old at time of recruitment
* Have capacity to consent
* Be assigned female sex at birth (may be gender diverse)
* Be active patients in the pediatric ED program at MCH
* Have a weight that is \<85% of the Treatment Goal Weight, as determined by the treating physician

Exclusion Criteria: Potential study subjects will be excluded due to the following reasons:

* Exposure to antibiotics within two weeks of study randomization
* Initiation of new probiotics / oral nutritional supplements within two weeks of randomization
* Active pregnancy
* Active psychosis or suicidal ideation
* Other comorbidities that may affect weight or the gut microbiome including celiac disease, inflammatory bowel disease (or other conditions as determined by the study team)

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, an average of one year.
measure: Retention Rate
timeFrame: Through study completion, an average of one year.
Secondary outcomes:
measure: Attitudes towards Fecal Microbiota Transplant
timeFrame: Week 12 (follow-up)
measure: Height
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Weight
timeFrame: Week 0 (baseline), Week 2, Week 4 (mid-treatment), Week 6, Week 8 (post-intervention), Week 10, Week 12 (follow-up)
measure: Eating Disorder Examination Questionnaire
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Beck Depression Inventory
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Beck Anxiety Inventory
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Yale-Brown-Cornell Eating Disorder Scale
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Gastrointestinal Symptom Rating Scale
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Changes in stool metabolites
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Changes in urine metabolomics
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Changes in saliva ultrafiltrates
timeFrame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)
measure: Changes in complete blood count
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in C-reactive protein
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in alkaline phosphatase
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in alanine aminotransferase
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in 25-OH Vitamin D
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in albumin
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in follicle stimulating hormone
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in luteinizing hormone
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Changes in free testosterone
timeFrame: Week 0 (baseline), Week 8 (post-intervention)
measure: Presence of safety outcomes
timeFrame: Through study completion, an average of one year.
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Jennifer L Couturier, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: