Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

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

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Procedure: Fecal microbiome transplantation

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital
    • Contact: Hong Koh; Phone Number: 82-2-2227-2050; Email: khong@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: FMT group; Group who received fecal microbiome transplantation

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission	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	6months after the Second FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome analysis by using relative abundance at phylum and genus level, beta diversity	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)	Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT
Clinical response using disease activity index		6 months after the Second FMT
Endoscopic healing		4 weeks after the First FMT
Adverse events	Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.	6 months after the Second FMT

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 4-2017-0223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No