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Completed

NCT Number: NCT03264690

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

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.

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Trial Site # 1, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion/ Exclusion Criteria:
  • 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)
  • Exclusion Criteria for IBD participants:
  • Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
  • Inclusion/ Exclusion Criteria:
  • 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
  • Exclusion Criteria for non-IBD participants:
  • Participants who have been on medication to treat underlying disease for the previous 3 months

Treatment and study plan

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: Up to 3 months

    Disease activity will be assessed by CDAI to quantify the symptoms.

  3. 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

    Time frame: Baseline; Month 3

    The composition of the microbiome at baseline will be correlated to disease activity which is assessed as measured by CDAI or Mayo score at Month 3.

  4. Change from baseline in calprotectin at Month 3

    Time frame: Baseline; Month 3

    Fecal calprotectin can indicate inflammation in the intestines.

  5. Number of participants with abnormal, clinically significant vital signs

    Time frame: Up to 3 months

    Clinical significance will be determined by the investigator.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

A Prospective 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

Acronym: ETERNITY

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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