Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease (SFMT-IBD)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335281
|Contact: Dongfeng Chen, firstname.lastname@example.org|
|Contact: Yanling Wei, email@example.com|
|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 firstname.lastname@example.org|
|Contact: Yanling Wei, doctor 86-15310354666 email@example.com|
|Study Director:||Dongfeng Chen, doctor||Third Military Medical University|