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Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

Primary Purpose

Inflammatory Bowel Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fecal microbiome transplantation
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT group

Arm Description

Group who received fecal microbiome transplantation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Clinical response using disease activity index
Endoscopic healing
Adverse events
Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.

Full Information

First Posted
December 18, 2017
Last Updated
January 15, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03399188
Brief Title
Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
Official Title
Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Inflammatory bowel disease patients in active stage.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT group
Arm Type
Experimental
Arm Description
Group who received fecal microbiome transplantation
Intervention Type
Procedure
Intervention Name(s)
Fecal microbiome transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical remission
Description
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
Time Frame
6months after the Second FMT
Secondary Outcome Measure Information:
Title
Microbiome analysis by using relative abundance at phylum and genus level, beta diversity
Description
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)
Time Frame
Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT
Title
Clinical response using disease activity index
Time Frame
6 months after the Second FMT
Title
Endoscopic healing
Time Frame
4 weeks after the First FMT
Title
Adverse events
Description
Any adverse events thought to be related to FMT will be measured throughout the follow-up period after FMT.
Time Frame
6 months after the Second FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Koh
Phone
82-2-2227-2050
Email
khong@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

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