Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

Not Applicable

• Conditions: Inflammatory Bowel Diseases
• Interventions: Procedure: Fecal microbiome transplantation

• Registration Number: NCT03399188
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FMT group	Fecal microbiome transplantation	Group who received fecal microbiome transplantation

Primary Outcome Measures

Name	Time	Method
Clinical remission	6months after the Second FMT	For Ulcerative Colitis patients Patients 18 years old and under: Pediatric ulcerative colitis activity index (PUCAI) less than 10.; It ranges from 0 to 85, with a higher score indicating greater severity of disease Patients over 18 years old: Partial Mayo score same or less than 1 It ranges from 0 to 9, with a higher score indicating greater severity of disease For Crohn's Disease patients Patients 18 years old and under: Pediatric Crohn's disease activity index (PCDAI) less than 10 It ranges from 0 to 100, with a higher score indicating greater severity of disease Patients over 18 years old: Crohn's disease activity index (CDAI) less than 150 It ranges from 0 to over 600, with a higher score indicating greater severity of disease

Secondary Outcome Measures

Name	Time	Method
Microbiome analysis by using relative abundance at phylum and genus level, beta diversity	Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT	* Microbial changes (increase of microbial diversity and improvement of firmicutes/bacteriodes ratio) in an early stage after FMT by using Relative abundance at phylum and genus level; * Microbial stability after FMT for one week (change in beta diversity)
Clinical response using disease activity index	6 months after the Second FMT
Endoscopic healing	4 weeks after the First FMT
Adverse events	6 months after the Second FMT	Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of