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Donor Microbiota of Fecal Microbiota Transplantation for CDI

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05703477
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
31.9
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fecal microbiota transplantation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation Therapy for Clostridium Difficile Infection
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Aug 30, 2022
Actual Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: FMT Responder

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.
Experimental: FMT non-Responder

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.

Outcome Measures

Primary Outcome Measures

  1. changes of microbiota before and after FMT treatment [7 days, 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  1. Intervention with antibiotics during treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Tenth People's Hospital Shanghai Shanghai China 200071

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

  • Principal Investigator: Hongliang Tian, 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, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT05703477
Other Study ID Numbers:
  • FMTCDI
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Clostridium Infections

Study Results

No Results Posted as of Jan 30, 2023