Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Nanjing Medical University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Bacteria; Inflammatory Bowel Disease; Ulcerative Colitis; Fecal Microbiota Transplantation; Microbiota

Treatments: Drug: Traditional treatments; Procedure: Standardized FMT

Study type: Interventional

Funder types: Other

Identifiers

NCT01790061

FMT-CN-121123

Details and patient eligibility

About

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).

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 6 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies.

Exclusion criteria

Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Standardized FMT

Experimental group

Description:

endoscopy Tubing Once or repeat

Treatment:

Procedure: Standardized FMT

Traditional treatments

Experimental group

Description:

Oral Tubing

Treatment:

Drug: Traditional treatments