Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

NCT ID: NCT01790061

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2025-12-31

Brief 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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standardized FMT

endoscopy Tubing Once or repeat

Group Type: EXPERIMENTAL

Standardized FMT

Intervention Type: PROCEDURE

Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon

Traditional treatments

Oral Tubing

Group Type: EXPERIMENTAL

Traditional treatments

Intervention Type: DRUG

Medications

Interventions

Standardized FMT

Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon

Intervention Type: PROCEDURE

Traditional treatments

Medications

Intervention Type: DRUG

Other Intervention Names

Fecal Microbiota Transplantation; Fecal Microbiota Therapy; fecal transplantation; Traditional treatments according to associated guidelines

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Associate professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huijie Zhang, MD,PhD

Role: STUDY_CHAIR

The Second Afiliated Hospital of Nanjing Medical University

Locations

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, MD,PhD

Role: CONTACT

fzhang@njmu.edu.cn

086-25-58509883

Faming Zhang, MD,PhD

Role: CONTACT

Facility Contacts

Faming Zhang, MD, PhD

Role: primary

fzhang@njmu.edu.cn

086-25-58509883

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23041678 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 2563083 (View on PubMed)

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Reference Type: DERIVED

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Related Links

http://www.ncbi.nlm.nih.gov/pubmed

Fecal microbiota transplantation

Other Identifiers

FMT-CN-121123

Identifier Type: -

Identifier Source: org_study_id