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临床试验/CTRI/2024/06/069390
CTRI/2024/06/069390尚未招募2/3 期

Gut-Brain-Microbiome interaction: modulation of the Gut Microbiome by Faecal Microbiota Transplantation (FMT) in patients of Functional Bowel Disorder with psychiatric comorbidity

Dr Jayeeta Bhowmick1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
1. Improvement of gut microbiota post FMT

研究概览

简要总结

Some evidence exists that Faecal Microbiota transplantation (FMT) can improve symptoms in patients with Functional Bowel Disorder (FBD) and may have some beneficial effects in patients with depression and anxiety. To the best of our knowledge, no study has investigated the effects of FMT on both enteric and psychiatric symptoms in patients with FBD and psychiatric comorbidity.

Objectives- 1. To compare the pattern of gut microbiota between FBD patients with psychiatric illness and that of healthy controls. 2. To develop a Faecal Microbiota Storage and Transplantation facility and conduct transplantation from healthy controls to FBD patients with psychiatric illness. 3. To assess whether FMT from healthy donors can alleviate the enteric and psychiatric symptoms of FBD patients with psychiatric illness. 4. To determine the temporal and constitutional dynamics of the transplanted microbiota in the recipient’s gut under various conditions.

Methodology- 1. We shall utilise state-of-the-art shotgun sequencing-based faecal metagenomics for assessing gut microbiota of the cases, controls and healthy donors at the baseline. 2. We shall conduct a pilot randomised controlled trial for our objectives 2 and 3 and follow up with our participants for one year.

Expected Outcomes among patients of FBD with psychiatric comorbidity after FMT- 1. Significant and sustained improvement of symptoms related to FBD and psychiatric conditions. 2. Significant and sustained modulation of Gut Microbiome composition. 3. The study will contribute to the knowledge base on the gut-brain-microbiome axis and the potential therapeutic use of FMT in patients with FBD and psychiatric comorbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adult Patients more than 18 years History of chronic gastrointestinal disorder Associated psychiatric co-morbidity.

排除标准

  • Patient with age less than 18 years or more than 70 years Current, active or past inflammatory bowel disease Refusal to give consent.

结局指标

主要结局

1. Improvement of gut microbiota post FMT

时间窗: 1. At baseline and total 12 months post FMT

2. Compare modulation of gut microbiota pre and post FMT by microbiome analysis.

时间窗: 1. At baseline and total 12 months post FMT

3.Coparison of IBS-SSS, IBS-QOL and GSRS scores as well as PHQ9, BAI and MDQ scores to determine improvement.

时间窗: 1. At baseline and total 12 months post FMT

次要结局

  • 1. Whether FMT works in IBS-D patients with psychiatric co-morbidity or not.(2. Observation & interpretation on mode of FMT to the effect.)

研究者

发起方
Dr Jayeeta Bhowmick
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Jayeeta Bhowmick

All India Institute of Medical Sciences(AIIMS), Kalyani

研究点 (1)

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