Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05990972

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea symptoms after the use of antibiotics, often combined with abdominal pain, bloating and bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. To explore the overall efficacy and safety of FMT in the treatment of AAD.

Condition or Disease	Intervention/Treatment	Phase
Fecal Microbiota Transplantation Antibiotic-associated Diarrhea	Procedure: Fecal Microbiota Transplantation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

To Investigate the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in the Treatment of Antibiotic-associated Diarrhea.

Actual Study Start Date :

Jul 20, 2020

Actual Primary Completion Date :

Apr 20, 2023

Actual Study Completion Date :

Jul 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FMT group	Procedure: Fecal Microbiota Transplantation Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.

Arm

Intervention/Treatment

Experimental: FMT group

Procedure: Fecal Microbiota Transplantation

Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.

Outcome Measures

Primary Outcome Measures

Changes in defecation frequency after FMT. [Baseline and three months after treatment]
Changes in gut microbiota after FMT. [Baseline and three months after treatment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

occurrence of antibiotic-associated diarrhoea; no response to standard therapy; agree to receive FMT and sign informed consent; willingness to provide stool samples.

Exclusion Criteria:

non-antibiotic-associated diarrhea; did not accept FMT or did not sign informed consent; unwillingness to provide stool samples.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University	Shanghai		China

Sponsors and Collaborators

Shanghai 10th People's Hospital

Investigators

Principal Investigator: Le Wang, Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huanlong Qin, Clinical Professor, Shanghai 10th People's Hospital

ClinicalTrials.gov Identifier:

NCT05990972

Other Study ID Numbers:

FMT-AAD

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diarrhea

Study Results

No Results Posted as of Aug 14, 2023