Registry of IBD Patients to Study Microbial Profiles
Understanding the Importance of the Microbiome and Metabolome in IBD Patients
This study is trying to understand the gut bacteria and their effects on people with inflammatory bowel disease by looking at different groups of patients at various stages of their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT04998084 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify common microbial profiles and metabolic pathways in patients with inflammatory bowel disease (IBD), including Crohn's disease, ulcerative colitis, and pouchitis. It will focus on three groups: newly diagnosed therapy-naïve patients, those starting biological therapy, and patients in complete remission. Data will be collected prospectively through a standardized protocol, involving clinical, behavioral, and environmental information from a target of 1000 participants. The study seeks to enhance understanding of microbial influences on disease onset and treatment response.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed therapy-naïve IBD patients, those in remission, and patients scheduled to start biological therapy.
Not a fit: Patients under 18 years old, those unable to provide consent, or with recent abdominal surgery or severe systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with IBD.
How similar studies have performed: Other studies have shown promise in understanding microbial profiles in IBD, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients who belong to one of the following sub-groups: 1. Newly diagnosed (\<1 years), therapy naïve IBD and pouchitis patients 2. IBD patients in complete remission (treated or untreated with biologics) 3. Patients (with and without IBD) scheduled to commence a biological therapy Exclusion Criteria: 1. Age≤18 years 2. Inability to sign an informed consent 3. Abdominal surgery during the previous 3 months 4. Systemic antibiotic therapy in the previous 4 weeks 5. Severe systemic disease such as kidney, liver, neurologic, cardio-vascular disease 6. Primary sclerosing cholangitis 7. Pregnancy at recruitment 8. Cancer within the previous 5 years excluding local NMSC
Where this trial is running
Tel Aviv
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Naomi fliss, Dr.
- Email: naomifl@tlvmc.gov.il
- Phone: 972-3-6947305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.