An interventional study of FMT through a naso-jejunal tube and FMT through TET in Inflammatory Bowel Diseases and Fecal Microbiota Transplantation, sponsored by Air Force Military Medical University, China. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment
The study aims to evaluate the clinical efficacy and safety of fecal microbiota transplantation by automatic methods in the treatment of moderate to severe active ulcerative colitis. There are two groups according to FMT pathway ( through a naso-jejunal tube or transendoscopic enteral tubing). Patients were followed up until 2 weeks after the final FMT in hospital.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's enrollment of 9 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
The purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.
Other: FMT through a naso-jejunal tube
The purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.
Other: FMT through TET
Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.
Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.
clinical response
reduction in the Mayo score of ≥3 points and ≥30% from baseline, with a decrease in the rectal bleeding subscore of ≥1 point or a subscore of ≤1
Time frame: 2 weeks after FMT
clinical remission, safety and progression of disease
clinical remission: Mayo score ≤ 2, with no subscore \> 1; progression of disease: measured by initiation of anti-TNFα or colectomy. Adverse event severity and relatedness was graded using NIH criteria.
Time frame: 2 weeks after FMT
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China