Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

Inflammatory Bowel Diseases Clinical Trial

Official title:

Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399188
• Other study ID #: 4-2017-0223
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical response using disease activity index		6 months after the Second FMT
Secondary	Endoscopic healing		4 weeks after the First FMT
Secondary	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