A Pilot Feasibility Randomized Controlled Trial of Fecal Microbiota Transplant for Adolescent Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All parties will be blinded to the participant's treatment arm.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Fecal Microbiota Transplant
Banked donor stools that have been previously screened, prepared and frozen per previous protocols will be used to prepare all oral FMT capsules (OFC) through the laboratory of a collaborator. Recipients will receive OFC (two capsules, twice a day, twice per week) prepared from a single donor throughout their 8-week treatment course, to support assessment of FMT engraftment in recipients; this totals to 64 capsules across the duration of the study. Each OFC will contain approximately 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule.
干预措施: Fecal Microbiota Transplant (Biological)
Placebo
Matching oral placebo capsules (OPC) containing methylcellulose will be identical in terms of size, colour, taste, and dosing. Participants will be asked to take the Placebo treatment capsules twice a day for two days per week for a duration of eight weeks (total 64 capsules).
干预措施: Placebo (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: Through study completion, an average of one year.
The number of participants who are consented into the study divided by the number of participants who show interest in the study.
Retention Rate
时间窗: Through study completion, an average of one year.
The number of participants who completed the study divided by the number of participants consented into the study.
次要结局
- Changes in complete blood count(Week 0 (baseline), Week 8 (post-intervention))
- Changes in C-reactive protein(Week 0 (baseline), Week 8 (post-intervention))
- Changes in alkaline phosphatase(Week 0 (baseline), Week 8 (post-intervention))
- Changes in alanine aminotransferase(Week 0 (baseline), Week 8 (post-intervention))
- Changes in 25-OH Vitamin D(Week 0 (baseline), Week 8 (post-intervention))
- Changes in albumin(Week 0 (baseline), Week 8 (post-intervention))
- Changes in follicle stimulating hormone(Week 0 (baseline), Week 8 (post-intervention))
- Changes in luteinizing hormone(Week 0 (baseline), Week 8 (post-intervention))
- Changes in free testosterone(Week 0 (baseline), Week 8 (post-intervention))
- Presence of safety outcomes(Through study completion, an average of one year.)
- Attitudes towards Fecal Microbiota Transplant(Week 12 (follow-up))
- Height(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Weight(Week 0 (baseline), Week 2, Week 4 (mid-treatment), Week 6, Week 8 (post-intervention), Week 10, Week 12 (follow-up))
- Eating Disorder Examination Questionnaire(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Beck Depression Inventory(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Beck Anxiety Inventory(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Yale-Brown-Cornell Eating Disorder Scale(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Gastrointestinal Symptom Rating Scale(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Changes in stool metabolites(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Changes in urine metabolomics(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
- Changes in saliva ultrafiltrates(Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up))
研究者
Jennifer Couturier
Associate Professor
McMaster University