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NCT05990972 Clinical Trial

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

Fecal Microbiota Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05990972
Other study ID # FMT-AAD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2020
Est. completion date July 20, 2023

Study information
Verified date August 2023
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 20, 2023
Est. primary completion date April 20, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 78 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
China Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University 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 Changes in defecation frequency after FMT. Baseline and three months after treatment
Primary Changes in gut microbiota after FMT. Baseline and three months after treatment.
See also
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