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.

January 23, 2024 updated by: Huanlong Qin, Shanghai 10th People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Le Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Intestinal barrier dysfunction. Inability to tolerate enteral nutrition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FMT group
Procedure: Fecal microbiota transplantation
Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota. Its basic principle involves extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing the therapeutic efficacy of patients after FMT.
Time Frame: 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.
0day, 7days, 30days, 3 months, 6months,12 months
Comparing the differences in microbiota composition in samples such as feces and small intestinal fluid from patients.
Time Frame: 0day, 7days, 30days, 3 months, 6months,12 months
Performing 16S rRNA sequencing, metagenomic sequencing, and metabolite analysis on the samples.
0day, 7days, 30days, 3 months, 6months,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Estimated)

December 10, 2025

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT-ALL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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