Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT04912999

Inflammatory Bowel Diseases Remission Registry

Led by Tel-Aviv Sourasky Medical Center · Updated on 2024-05-16

1000

Participants Needed

1

Research Sites

352 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Inflammatory Bowel Diseases Remission Registry

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Crohn's disease, ulcerative colitis, or pouchitis for at least 2 months
  • In clinical and biological remission defined by Steroid free clinical remission for 3 months or more
  • Harvey Bradshaw Index less than 5 for Crohn's disease patients
  • Simple Clinical Colitis Activity Index 2 or less for ulcerative colitis patients
  • Pouch Disease Activity Index 6 or less / mPDAI 4 or less for pouchitis patients
  • Age between 18 and 80 years
  • Clinically stable patients on a constant medication regimen (mesalamine for at least 4 weeks, immunomodulators for at least 12 weeks, biologics for at least 12 weeks, or medical cannabis for at least 2 weeks before study entry)
Not Eligible

You will not qualify if you...

  • Unable to sign informed consent or complete the study protocol
  • Use of steroid therapy within the past 3 months
  • Use of antibiotic therapy within the past 2 weeks
  • Unstable or uncontrolled medical disorder or severe systemic disease other than IBD
  • Currently participating in another clinical interventional trial
  • Presence of a stoma

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Tel Aviv Medical Center; ,

Tel Aviv, Israel, 64239

Actively Recruiting

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Research Team

N

Nitsan Maharshak, Professor

CONTACT

R

Rony Izhar, Dr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Inflammatory Bowel Diseases Remission Registry | DecenTrialz