跳至主要内容
临床试验/NCT05834010
NCT05834010已完成早期 1 期

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

Hvidovre University Hospital3 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年3月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
17
试验地点
3
主要终点
Feasibility of FMT in AN patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

FMT

Experimental

rectal or oral route FMT

干预措施: Fecal Microbiome Transplant (Biological)

结局指标

主要结局

Feasibility of FMT in AN patients

时间窗: 2 years

The recruitment and compliance of 10-20 patients/year is feasible

Preferred route of FMT (questionnaire)

时间窗: 2 years

FMT is offered as a Capsule-treatment orally or as an enema-rectally

次要结局

  • 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(2 yrs)
  • A single FMT treatment can alter GM composition in AN patients short term(2 yrs)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Munk Petersen

Dr. MD pHD Clinical Associate Research Professor

Hvidovre University Hospital

研究点 (3)

Loading locations...

相似试验