Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

NCT ID: NCT03399188

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2023-12-31

Brief Summary

Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.

Detailed Description

Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.

Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.

Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMT group

Group who received fecal microbiome transplantation

Group Type: EXPERIMENTAL

Fecal microbiome transplantation

Intervention Type: PROCEDURE

Fecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation.

Interventions

Fecal microbiome transplantation

Fecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 7 years old to 80 years old at start of trial
• Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
• Patients who do not respond to the conventional treatments or who do not wish/not able to use one.
• Patients who agree to participate in the trial after thorough explanation
• Evidence of active disease

Exclusion Criteria

• Patients whose CRP<8, calprotectin<200, and mucosal healing endoscopically (who are in stable state)
• Patients whose symptom is due to other disease than IBD

_Patients with immunosuppressive disease

• Patients who are clinically unstable such as massive hemorrhage or perforation
• Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
• Absolute neutrophil count (ANC) <1.5 *10^9/L (1500/mm3)
• Pregnant or under breast feeding
• Patients enrolled in other clinical trials

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Hong Koh

Role: primary

khong@yuhs.ac

82-2-2227-2050

Other Identifiers

4-2017-0223

Identifier Type: -

Identifier Source: org_study_id