Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease (SFMT-IBD)
|ClinicalTrials.gov Identifier: NCT02335281|
Recruitment Status : Unknown
Verified January 2015 by Yanling Wei, Third Military Medical University.
Recruitment status was: Recruiting
First Posted : January 9, 2015
Last Update Posted : January 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease||Procedure: FMT Drug: Mesalazine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Standardized FMT
The group include 20 patients. They will receive standardized FMT. The FMT was given to mid-gut by nose-jejunum nutrition tube. It was given only once.
Standardized FMT once
Active Comparator: Mesalazine
This group include 20 patients . The patients will receive traditional medicine of mesalazine treatment.
2g Po perday
Other Name: Mesalamine
- Clinical remission (defined as HBI score ≦ 4) [ Time Frame: up to one year ]Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence
- Hospitalization days [ Time Frame: up to one year ]Hospitalization days from administration to discharge when at clinical remission.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335281
|Contact: Dongfeng Chen, email@example.com|
|Contact: Yanling Wei, firstname.lastname@example.org|
|Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University||Recruiting|
|Chongqing, Chongqing, China, 400042|
|Contact: Dongfeng Chen, doctor 86-13883032812 email@example.com|
|Contact: Yanling Wei, doctor 86-15310354666 firstname.lastname@example.org|
|Study Director:||Dongfeng Chen, doctor||Third Military Medical University|