Registry for patients with inflammatory bowel diseases in remission
The Inflammatory Bowel Diseases Remission Registry
This study is tracking people with Crohn's disease and ulcerative colitis who are in remission to see how their daily habits and body rhythms might affect their chances of having a flare-up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT04912999 on ClinicalTrials.gov |
What this trial studies
This observational study aims to follow patients with inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis, who are currently in remission. The study will collect clinical, behavioral, dietary, and environmental data to identify risk factors and early signs of disease exacerbation. Participants will be monitored for at least one year or until a relapse occurs, with a focus on understanding the relationship between circadian rhythm changes and disease activity. The research is conducted at the Tel Aviv Medical Center under the guidance of Dr. Nitsan Maharshak.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of Crohn's disease, ulcerative colitis, or pouchitis who are in clinical and biochemical remission.
Not a fit: Patients currently undergoing steroid therapy or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify risk factors for relapse in inflammatory bowel disease patients, leading to improved management and prevention strategies.
How similar studies have performed: While there have been studies on IBD management, this specific approach focusing on prospective data collection for relapse prediction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed as suffering from Crohn's disease (CD), Ulcerative colitis (UC) or Pouchitis for at least 2 months who are in clinical and biologic remission according to Steroid free clinical remission for greater or equal to 3 months according to the following activity index * Harvey Bradshaw index (HBI)\<5 for CD patients * Simple Clinical Colitis activity index (SCCAI)≤2 for UC patients * Pouch disease activity index ≤6 / mPDAI ≤4 for Pouch patients Also, patients will be included if they fullfull the following: * Age 18-80 years * Clinically stable patients, on constant medicinal regimen (mesalamine at least 4 weeks, or immunomodulators at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before inclusion to the study) Exclusion Criteria: * • Inability to sign an informed consent and complete the study protocol * Steroid therapy during the past 3 months * Antibiotic therapy during the past 2 weeks * Unstable or uncontrolled medical disorder, and sever systemic disease (other than IBD) * Participating in another clinical interventional trial * Stoma
Where this trial is running
Tel Aviv
- Tel Aviv Medical Center; , — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Nitsan Maharshak, Professor
- Email: nitsanm@tlvmc.gov.il
- Phone: 972-36972428
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.