Analyzing gut microbiome data in inflammatory bowel disease

Building an Integrated Gut Microbiome Data Analysis Platform and Conducting Comparative Clinical Studies in Inflammatory Bowel Disease

This study is trying to understand how gut bacteria and genetics affect treatment responses in people with inflammatory bowel disease to help improve personalized care.

Quick facts

• Study type: Observational
• Enrollment: 900 (estimated)
• Ages: 13 Years to 85 Years
• Sex: All
• Sponsor: Kyunghee University Medical Center (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06124833 on ClinicalTrials.gov

What this trial studies

This observational study focuses on inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis, affecting millions globally. It aims to create a multi-omics analysis platform using biosamples from IBD patients and their families to identify clinical risk factors, genetic variations, and microbiome markers. The study will compare responders and non-responders to treatments, develop predictive biomarkers, and establish guidelines for precision treatment based on multi-omics data. By understanding the interplay of genetic and environmental factors, the research seeks to clarify the pathophysiology of IBD.

Who should consider this trial

Good fit: Ideal candidates include Korean patients aged 13 to 85 with a diagnosis of inflammatory bowel disease and their first-degree relatives who have never been diagnosed with IBD.

Not a fit: Patients with indeterminate colitis or those in the family control group with specific medication histories or recent vaccinations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies for patients with inflammatory bowel disease.

How similar studies have performed: While there have been studies exploring the gut microbiome in IBD, this multi-omics approach is relatively novel and aims to provide deeper insights into the disease.

Eligibility criteria

Inclusion Criteria:

1. Korean patients with inflammatory bowel disease (including Crohn's disease and ulcerative colitis) aged between 13 and 85 years (at the time of participant consent).
2. First-degree blood relatives of the patient, aged between 13 and 85, who have never been diagnosed with IBD and reside with the patient (Family Control Group).
3. Participants who have received a detailed explanation about this clinical trial, fully understand it, have voluntarily decided to participate, and have given written consent to comply with the precautions.

Exclusion Criteria:

* For IBD patients

  1\. Indeterminate colitis.
* For family control group

  1. Individuals with a history of using medications listed in Appendix 13 (Family Control Group Medication History) within a pre-specified period before the microbiome collection date.
  2. Individuals who have been vaccinated within the last month (4 weeks) prior to the microbiome collection date.
  3. Individuals who have applied topical antibiotics or topical steroids to the face, scalp, neck, or arms, forearms, hands within 24 hours prior to the microbiome collection date.
  4. Individuals who have used vaginal/external genital medications, including antifungals, within 24 hours prior to the microbiome collection date.
  5. Individuals with acute conditions (e.g., moderate or severe diseases with or without fever; however, sample collection can be postponed until the participant recovers).
  6. Individuals with chronic and clinically significant histories of liver, digestive, cardiovascular, renal, neurological, respiratory, endocrine, immune, hematological disorders, malignancies, psychiatric conditions, or a history of drug abuse.
  7. Individuals who have drastically changed their diet for rapid weight gain or loss within 4 weeks prior to the microbiome collection date.
  8. Individuals with gastrointestinal disorders that could impact microbiome analysis and are not currently medically managed or individuals under treatment for the following conditions: Inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), Irritable bowel syndrome (requiring drug therapy), Ulcers, acute or chronic pancreatitis, etc.
  9. Individuals requiring the use of incontinence diapers.
  10. Individuals with a positive urine pregnancy test, or who are pregnant or breastfeeding.
  11. Individuals suspected of having medical findings that may affect the sample collection at the time of microbiome sample collection.

Where this trial is running

Seoul

• Kyunghee University Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Chang Kyun Lee, MD, PhD — Kyunghee University Medical Center
• Study coordinator: Chang Kyun Lee, MD, PhD

Conditions: Inflammatory Bowel Disease, Microbiota, Multiomics, Gut Microbiome, Oral Microbiome, Metabolome