Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 30
• Participant gender: Both

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 (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This is an initial step into investigating the potential efficacy of fecal bacteriotherapy for CD, the investigators propose to determine the efficiency, durability and safety of FMT in a series of 30 patients with CD (included cased according Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3 but without perianal diseases).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second Hospital of Nanjing Medical University
• Collaborator: Fourth Military Medical University
• Treatments: Azathioprine; Infliximab; Prednisone
• Last Updated: 2014-11-21

Criteria

Inclusion Criteria:

• Severe CD define as HBI score ≥ 9.

• Moderate CD define as 7- Montreal classification: Age > 14 years old, Location L1-3, Behavior B1-3.

Exclusion Criteria:

• Diarrhea activity scores < 3)

• Severely active disease with perianal diseases

• Severely active disease with indication of surgery.

• Diagnosis as CD first time or first year.

• No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy