Donor Microbiota of Fecal Microbiota Transplantation for CDI

Study Overview
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Brief Summary
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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.

Official Title
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Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation Therapy for Clostridium Difficile Infection

Conditions
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Clostridium Difficile Infection, Fecal Microbiota Transplantation

Intervention / Treatment
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* Procedure: Fecal microbiota transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT Responder<br> | Procedure: Fecal microbiota transplantation<br>* 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.<br>|
| Experimental: FMT non-Responder<br> | Procedure: Fecal microbiota transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of microbiota before and after FMT treatment |  | 7 days, 1 month |