Inflammatory Bowel Diseases Remission Registry

NCT04912999 | Recruiting

• 1 other identifier: 0268-19-TLV
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Ulcerative Colitis; Pouchitis

Outcome Measures

Primary Outcomes (3)

• 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:

  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:

  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:

  follow up for at least one year or until relapse time or until 2 years of follow up

Secondary Outcomes (3)

• nutritional factors as a risk of disease exacerbation

  at baseline and follow up visits (until 2 years of follow up) or until relapse

• o Circadian rhythm as a risk factor for relapse

  follow up for at least one year or until relapse time

• o Stress as a risk factor for relapse

  follow up for at least one year or until relapse time

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center; ,

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Pouchitis

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Ileitis; Enteritis; Ileal Diseases

Central Study Contacts

Nitsan Maharshak, Professor

CONTACT

972-36972428; nitsanm@tlvmc.gov.il

Rony Izhar, Dr

CONTACT

972-37772613; ronyi@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: June 3, 2021
• Study Start: August 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)