RecruitingNCT04912999

Inflammatory Bowel Diseases Remission Registry

The Inflammatory Bowel Diseases Remission Registry


Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

1,000 participants

Start Date

Aug 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

The inflammatory bowel diseases (IBDs), ulcerative colitis (UC) and Crohn's disease (CD), are characterized by lifelong relapsing-remitting gastrointestinal inflammation, with symptoms of abdominal pain, diarrhea, and rectal bleeding during active disease. Medical therapy reduces intestinal inflammation and ameliorates symptoms. Clinical remission is defined when symptoms are resolved. In these periods, patients are able to perform daily activities more freely and lead a normal lifestyle. Biochemical remission (normalization of CRP and fecal Calprotectin) and endoscopic remission (no visual signs of inflammation of the mucosa in endoscopy) are the goals of IBD treatment. Unfortunately, 30-40% of patients will relapse during 6 months from achieving remission. Risk factors for disease exacerbation are still unknown, and no guidelines exist as to the prevention of relapse and maintenance of remission in IBD patients. In addition to the above, sleep disturbances and disturbances in the circadian rhythm can be a potential cause of flare-up. Sleep disorders cause changes in immune function, which later affect the course of the disease in IBD. This back affects the sleep pattern, so that a cycle is created, which may perpetuate the inflammation. The interactions between sleep and inflammation are complex. An effective immune system affects sleep, and sleep disorders affect the functioning of the immune system. Furthermore, changes in the biological clock and sleep deprivation have been directly shown to worsen ulcerative colitis in laboratory animals. In people with sleep disorders, high levels of inflammation were found. However, it is difficult to dissect the cause and effect for these associations, given their complex interactions. Therefore we are planning to conduct a prospective study to assess variety of factors that might be associated with the activity of IBD.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tracks patients with Crohn's disease, ulcerative colitis, or pouchitis who are in remission (their disease is under control) to better understand what keeps people in remission and to build a registry of patients with inflammatory bowel disease (IBD). **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with Crohn's disease, ulcerative colitis, or pouchitis for at least 2 months - You are currently in remission (no active symptoms) and have been off steroids for at least 3 months - You are on a stable medication regimen (mesalamine, immunomodulators, biologics, or medical cannabis) **You may NOT be eligible if...** - You cannot sign informed consent - You have used antibiotics in the past 2 weeks - You have been on steroids in the past 3 months - You have a stoma (surgical bowel opening) - You have other serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Tel Aviv Medical Center; ,

Tel Aviv, Israel

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04912999


Related Trials