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Single fecal microbiota transplantation failed to change intestinal microbiota and had limited effectiveness against ulcerative colitis in Japanese patients
- Source :
- Intestinal Research, Intestinal Research, Vol 15, Iss 1, Pp 68-74 (2017)
- Publication Year :
- 2016
-
Abstract
- Background/aims Recent developments in analytical techniques including next-generation sequencing have clarified the correlation between intestinal microbiota and inflammatory bowel disease. Fecal microbiota transplantation (FMT) for patients with ulcerative colitis (UC) is proposed as a potential approach to resolving their dysbiosis; however, its safety and efficacy have not been confirmed. This single-arm, open-label, non-randomized study aimed to evaluate the safety and efficacy of FMT for Japanese patients with UC as the first registered clinical trial in Japan. Methods We enrolled 10 patients with active UC despite medical therapy. The donors were the patients' relatives and were carefully screened for infectious diseases. Fecal material was administered via colonoscopy, and the primary endpoint was the presence or absence of serious adverse events related to FMT. The secondary endpoint was a change in partial Mayo score at 12 weeks post-FMT. Scores ≤2 were considered a clinical response. Fecal samples were collected to follow changes in gut microbiota, while extracted complementary DNA were analyzed by a next-generation sequencer. We obtained written informed consent from all patients and donors. This study was approved by our Institutional Review Board and is registered in the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN 000012814). Results Five patients with moderate disease and five with severe disease were enrolled. No severe adverse effects were observed. One patient achieved clinical response; however, none of the patients' microbiota diversity recovered to the donor levels. Conclusions The use of single FMT for UC was safe; however, we failed to show its clinical efficacy and potential to change the intestinal microbiota.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
Colonoscopy
lcsh:Medicine
Gut flora
Inflammatory bowel disease
Colitis, ulcerative
Fecal microbiota transplantation
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
Clinical endpoint
lcsh:RC799-869
Adverse effect
biology
medicine.diagnostic_test
business.industry
lcsh:R
Gastroenterology
biology.organism_classification
medicine.disease
Ulcerative colitis
Clinical trial
030104 developmental biology
Dysbiosis
030211 gastroenterology & hepatology
lcsh:Diseases of the digestive system. Gastroenterology
Original Article
business
Subjects
Details
- ISSN :
- 15989100
- Volume :
- 15
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Intestinal research
- Accession number :
- edsair.doi.dedup.....c534aaf25ed3e993123f39ced32e1eac