The Safety and Efficacy of Fecal Microbiota Transplantation in the Treatment of Digestive Diseases and Non-digestive System Diseases Associated With Gastrointestinal Symptoms in the Gastrointestinal Tract.

Not Applicable

Recruiting

• Conditions: Fecal Microbiota Transplantation
• Interventions: Procedure: Fecal microbiota transplantation

• Registration Number: NCT06208930
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

The exploration of the safety and efficacy of fecal microbiota transplantation in the treatment of non-digestive system diseases associated with gastrointestinal symptoms in the gastrointestinal tract, while also investigating the impact of fecal microbiota transplantation on the intestinal system, and assessing the improvement of symptoms in other systems.Simultaneously optimizing the conditions during the FMT process, identifying the most effective treatment methods to enhance the therapeutic outcomes of FMT.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Status Verified: 2024-01
• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-01-07
• Study First Posted: 2024-01-17
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2025-12-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Being able to tolerate a nasoenteric tube or swallow a capsule.

Exclusion Criteria

• Intestinal barrier dysfunction. Inability to tolerate enteral nutrition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
FMT group	Fecal microbiota transplantation	-

Primary Outcome Measures

Name	Time	Method
Comparing the differences in microbiota composition in samples such as feces and small intestinal fluid from patients.	0day, 7days, 30days, 3 months, 6months,12 months	Performing 16S rRNA sequencing, metagenomic sequencing, and metabolite analysis on the samples.
Comparing the therapeutic efficacy of patients after FMT.	0day, 7days, 30days, 3 months, 6months,12 months	Through conducting relevant questionnaire surveys with patients, we can gain insights into the therapeutic efficacy of patients after undergoing FMT.

Trial Locations

Locations (1)

Le Wang; 🇨🇳 Shanghai, Shanghai, China