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 (ETERNITY)

Eisai

Status: Completed

Conditions: Inflammatory Bowel Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03264690

D2E7-M082-602

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion/ Exclusion Criteria:

   1. Inclusion Criteria For Inflammatory Bowel Disease (IBD) participants:

      • 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)

   2. Exclusion Criteria for IBD participants:

      • Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.

2. Inclusion/ Exclusion Criteria:

   1. Inclusion Criteria for non-IBD participants:

      • 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

   2. Exclusion Criteria for non-IBD participants:

      • Participants who have been on medication to treat underlying disease for the previous 3 months

Trial design

40 participants in 1 patient group

Microbial composition measured from IBD and non-IBD groups

Description:

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