An observational study in Crohn Disease, Ulcerative Colitis and Pouchitis, sponsored by Tel-Aviv Sourasky Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Tel-Aviv Sourasky Medical Center · Observational
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.
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 and complete the study protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Disease exacerbation for CD patients
Disease exacerbation by any of the following: * Increase in the specific clinical score: o Harvey Bradshaw index (HBI)≥5 for CD patients. HBI score ranges from 0 to 16 or more and the highest score depends on the number of liquid stools per day and indicates disease severity/activity * A change in disease activity requiring a change in medication, hospitalization, or a surgery. sample will be collected at baseline and follow up visits:
Time frame: 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: * Increase in the specific clinical score: o Simple Clinical Colitis activity index (SCCAI)\>2 for UC patients. SCCAI score ranges from 0 to 19 and the highest score indicates disease severity/activity * A change in disease activity requiring a change in medication, hospitalization, or a surgery. sample will be collected at baseline and follow up visits:
Time frame: 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: * Increase in the specific clinical score: o Pouch disease activity index (mPDAI) \>4 for Pouch patients. mPDAI score ranges from 0 to 6 and the highest score indicates disease severity/activity * A change in disease activity requiring a change in medication, hospitalization, or a surgery. sample will be collected at baseline and follow up visits:
Time frame: follow up for at least one year or until relapse time or until 2 years of follow up
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
Time frame: at baseline and follow up visits (until 2 years of follow up) or until relapse
o Circadian rhythm as a risk factor for relapse
• Circadian rhythm questionnaire will be collected at baseline and foloow up visits
Time frame: 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
Time frame: follow up for at least one year or until relapse time
Plan to share: No
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