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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.
Prospectively follow IBD patients in remission (both clinical and biochemical) until disease exacerbation.
• Specific aims:
Study design:
Study population:
Eligible IBD patients treated at the IBD clinic in the Tel Aviv Medical Center participating in the study, which have signed an informed consent form and answered to all the study inclusion criteria. Patients will be informed of the study by their treating physician, recruited and followed throughout the follow-up period by study co-ordinators.
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| Measure | Description | Time Frame |
|---|---|---|
| Disease exacerbation for CD patients | Disease exacerbation by any of the following:
sample will be collected at baseline and follow up visits: | follow up for at least one year or until relapse time or until 2 years of follow up |
| Disease exacerbation in UC patients | Disease exacerbation by any of the following:
sample will be collected at baseline and follow up visits: | follow up for at least one year or until relapse time or until 2 years of follow up |
| Disease exacerbation in UC-Pouch patients | Disease exacerbation by any of the following:
sample will be collected at baseline and follow up visits: | follow up for at least one year or until relapse time or until 2 years of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| nutritional factors as a risk of disease exacerbation | Questionnaires will be collected at baseline and follow up visits (dietary consumption) • Food frequency questionnaire, Processed foods questionnaire (PFQ), Lifestyle questionnaire | at baseline and follow up visits (until 2 years of follow up) or until relapse |
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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
Also, patients will be included if they fullfull the following:
Exclusion Criteria:
• Inability to sign an informed consent and complete the study protocol
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Eligible IBD patients treated at the IBD clinic in the Tel Aviv Medical Center participating in the study, which have signed an informed consent form and answered to all the study inclusion criteria. Patients will be informed of the study by their treating physician, recruited and followed throughout the follow-up period by study co-ordinators.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitsan Maharshak, Professor | Contact | 972-36972428 | nitsanm@tlvmc.gov.il | |
| Rony Izhar, Dr | Contact | 972-37772613 | ronyi@tlvmc.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Medical Center; , | Recruiting | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D019449 | Pouchitis |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| o Circadian rhythm as a risk factor for relapse |
• Circadian rhythm questionnaire will be collected at baseline and foloow up visits |
| follow up for at least one year or until relapse time |
| o Stress as a risk factor for relapse | • Promise questionnaire will be collected at baseline and follow up visits | follow up for at least one year or until relapse time |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D007079 | Ileitis |
| D004751 | Enteritis |
| D007077 | Ileal Diseases |