Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients

NCT03264690 | Completed

• 1 other identifier: D2E7-M082-602
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

This study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor necrosis factor (anti-TNF) treatment.

Conditions

Inflammatory Bowel Disease

Keywords

Crohn's disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3

  Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.

  Month 3

Secondary Outcomes (5)

• The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants

  Baseline

• Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC)

  Up to 3 months

• Correlation in the composition of the microbiome at baseline and disease activity will be assessed as measured by CDAI or Mayo score at Month 3

  Baseline; Month 3

• Change from baseline in calprotectin at Month 3

  Baseline; Month 3

• Number of participants with abnormal, clinically significant vital signs

  Up to 3 months

Study Arms (1)

Microbial composition measured from IBD and non-IBD groups

Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female participants diagnosed with inflammatory bowel disease (IBD) will be compared to participants with non-IBD.

You may not qualify if:

• Male or female, age ≥ 19 years at the time of informed consent
• Confirmed diagnosis of IBD
• Participants who are naïve to anti-tumour necrosis factor (anti-TNF)
• Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
• Participants who have not been diagnosed with IBD
• Participants who don't have any other intestinal disease except IBD
• Participants who are naïve to anti-TNF
• Participants who have been on medication to treat underlying disease for the previous 3 months

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (3)

Eisai Trial Site # 1

Seoul, South Korea

Location

Eisai Trial Site # 2

Seoul, South Korea

Location

Eisai Trial Site # 3

Seoul, South Korea

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: September 21, 2017
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: March 10, 2020

Record last verified: 2019-11

Locations

KR (3)