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

Inclusion Criteria7

  • 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 Criteria6

  • • 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

Locations(1)

Tel Aviv Medical Center; ,

Tel Aviv, Israel

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NCT04912999


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