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Completed

NCT Number: NCT05703477

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

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.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Fecal Microbiota Transplantation Gram-Positive Bacterial Infections Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged over 18 years old;
  • positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase;
  • can tolerate nasojejunal tube and complete full course of FMT treatment;
  • the clinical data are relatively complete and there is follow-up available for evaluation

Exclusion criteria

  • accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
  • 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

Treatment and study plan

Fecal Microbiota Transplantation

Procedure

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.

Primary outcomes

  1. changes of microbiota before and after FMT treatment

    Time frame: 7 days, 1 month

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2023
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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