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NCT05703477 Clinical Trial

The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection

Clostridium Difficile Infection Clinical Trial

Official title:
The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05703477
Other study ID # FMTCDI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date August 30, 2022

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

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. Recently, FMT has been widely used in the treatment of various gastrointestinal diseases, including but not limit in CDI. In this study, we focused on the demonstration of FMT action mechanism in CDI treatment.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. aged over 18 years old; 2. positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase; 3. can tolerate nasojejunal tube and complete full course of FMT treatment; 4. the clinical data are relatively complete and there is follow-up available for evaluation Exclusion Criteria: 1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism; 2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Fecal microbiota transplantation
Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.

Locations
Country Name City State
China Shanghai Tenth People's Hospital 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 changes of microbiota before and after FMT treatment 7 days, 1 month
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