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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inflammatory Bowel Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Microbial composition measured from IBD and non-IBD groups<br>Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants | 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. | Baseline | 
| Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC) | Disease activity will be assessed by CDAI to quantify the symptoms. | 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 | 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. | Baseline; Month 3 | 
| Change from baseline in calprotectin at Month 3 | Fecal calprotectin can indicate inflammation in the intestines. | Baseline; Month 3 | 
| Number of participants with abnormal, clinically significant vital signs | Clinical significance will be determined by the investigator. | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Ulcerative colitis