Trials / Recruiting
RecruitingNCT01790061
Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- The Second Hospital of Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 6 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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 500 patients with moderate to severe UC (Montreal classification).
Detailed description
The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota 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(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Standardized FMT | Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon |
| DRUG | Traditional treatments | Medications |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2013-02-13
- Last updated
- 2024-04-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01790061. Inclusion in this directory is not an endorsement.