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NCT06208930 Clinical Trial

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.

Fecal Microbiota Transplantation Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06208930
Other study ID # FMT-ALL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date December 10, 2025

Study information
Verified date January 2024
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date December 10, 2025
Est. primary completion date December 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China Le Wang Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparing the therapeutic efficacy of patients after FMT. 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
Primary Comparing the differences in microbiota composition in samples such as feces and small intestinal fluid from patients. Performing 16S rRNA sequencing, metagenomic sequencing, and metabolite analysis on the samples. 0day, 7days, 30days, 3 months, 6months,12 months
See also
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Recruiting NCT03325855 - Fecal Microbiota Transplant National Registry
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Active, not recruiting NCT05607745 - Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study N/A
Completed NCT05121285 - Distribution of FMT After Delivery by · Lower GI Endoscopy vs Enema With and Without Positioning of the Patient N/A
Active, not recruiting NCT05917379 - The Safety and Efficacy of FMT in Patients With CID Phase 1/Phase 2
Recruiting NCT02318147 - Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC) Phase 1
Completed NCT02318134 - Fecal Microbiota Transplantation for Pancreatitis Phase 2
Completed NCT05035784 - RCE With FMT in the Treatment of Childhood Constipation N/A
Active, not recruiting NCT04173208 - Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study N/A
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Recruiting NCT05273255 - Fecal Microbiota Transplantation in Patients With Malignancies Not Responding to Cancer Immunotherapy N/A
Not yet recruiting NCT05253222 - Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET N/A
Recruiting NCT04285424 - FMT for Steroid Resistant Gut Acute GVHD Early Phase 1
Withdrawn NCT03527056 - Pilot Study Using Oral Capsule FMT to Decolonize GI CRE Early Phase 1