Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
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Purpose
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 60 patients with moderate to severe UC (Montreal classification).
| Condition | Intervention | Phase |
|---|---|---|
|
Bacteria Flora Fecal Microbiota Transplantation Inflammatory Bowel Disease Ulcerative Colitis |
Procedure: Standardized Fecal Microbiota Transplantation Drug: Traditional treatments according to associated guidelines |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis |
- durability of clinical remission [ Time Frame: One month ] [ Designated as safety issue: No ]The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)
- Patients with worsened disease [ Time Frame: one year ] [ Designated as safety issue: No ]Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.
- Adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]Number of adverse events.
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Standardized Fecal Microbiota Transplantation
Standardized Fecal Microbiota Transplantation, once.
|
Procedure: Standardized Fecal Microbiota Transplantation
Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut (below the second part of duodenum).
Other Names:
|
|
Sham Comparator: Traditional treatments
Traditional treatments according to associated guidelines
|
Drug: Traditional treatments according to associated guidelines
Traditional treatments according to associated guidelines
Other Name: Traditional treatments according to associated guidelines
|
Detailed Description:
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT only once or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests , endoscopy and questionnaire will be used to assess participants at study start and at study completion.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Mild to moderate UC (Montreal classification)
Exclusion Criteria:
Diagnosed as UC first time. No history of using Biologic,immunomodulatory therapy or corticosteroid therapy.
With contraindication of endoscopy.
Contacts and Locations| Contact: Faming Zhang, MD,PhD | 086-25-58509883 | fzhang@njmu.edu.cn |
| Contact: Huijie Zhang, MD, PhD | 086-25-58509670 | zhjssm@163.com |
| China, Jiangsu | |
| Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Recruiting |
| Nanjing, Jiangsu, China, 210011 | |
| Contact: Faming Zhang, MD, PhD 086-25-58509883 fzhang@njmu.edu.cn | |
| Contact: Huijie Zhang, MD, PhD 086-25-58509670 zhjssm@163.com | |
More Information
Additional Information:
Publications:
| Responsible Party: | Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University |
| ClinicalTrials.gov Identifier: | NCT01790061 History of Changes |
| Other Study ID Numbers: | FMT-CN-121123 |
| Study First Received: | February 9, 2013 |
| Last Updated: | February 13, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by The Second Hospital of Nanjing Medical University:
|
Gut bacteria Gut flora Bacteriotherapy |
Fecal Microbiota Transplantation Inflammatory bowel disease Ulcerative colitis |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Inflammatory Bowel Diseases Intestinal Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013