Crohn DiseaseNCT04912999
Inflammatory Bowel Diseases Remission Registry
An observational study of Crohn Disease and Ulcerative Colitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Pouchitis
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2019to 1 May 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center; ,
Tel Aviv, 64239
Nitsan Maharshak, Professor, 972-36972428, nitsanm@tlvmc.gov.il
About this study
Official title: The Inflammatory Bowel Diseases Remission Registry
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.
Read more
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.
Read the detailed description
Prospectively follow IBD patients in remission (both clinical and biochemical) until disease exacerbation.
- Specific aims:
- To detect risk factors and early signs for disease exacerbation in IBD patients.
- To detect predictors of disease exacerbation from environmental and behavioral characteristics of patients, clinical and biochemical characteristics of the disease.
- To examine whether changes in circadian rhythm are associated with improvement in clinical and biological disease activity
Study design:
- A prospective cohort study. Eligible patients will be follow up for at least one year or until relapse time.
- Setting: prospectively collect clinical, behavioral, dietary and environmental data of IBD patients currently declared in an endoscopic remission according to the criteria in Israel. Data will be collected according to a uniform standardized protocol specifically adapted to the needs of the study. The team will include members of the IBD clinic at the Tel Aviv Medical Center, run by Dr. Nitsan Maharshak.
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.
- Conditions
- Crohn Disease, Ulcerative Colitis, Pouchitis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Pouchitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease exacerbation for CD patients
Disease exacerbation by any of the following:
- Increase in the specific clinical score:
- 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:
Measured: 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:
- 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:
Measured: 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:
- 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:
Measured: 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
Questionnaires will be collected at baseline and follow up visits (dietary consumption)
- Food frequency questionnaire, Processed foods questionnaire (PFQ), Lifestyle questionnaire
Measured: 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
Measured: 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
Measured: follow up for at least one year or until relapse time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Aug 2019
- Primary completion1 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912999
- Sponsor's protocol ID
- 0268-19-TLV
- Status last verified
- May 2024
- First submitted
- 24 Mar 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inflammatory Bowel Diseases Remission Registry
- ClinicalTrials.gov ID
- NCT04912999
- Acronym / sponsor ID
- 0268-19-TLV
- Conditions
- Crohn Disease, Ulcerative Colitis, Pouchitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospectively follow IBD patients in remission (both clinical and biochemical) until disease exacerbation.
- Specific aims:
- To detect risk factors and early signs for disease exacerbation in IBD patients.
- To detect predictors of disease exacerbation from environmental and behavioral characteristics of patients, clinical and biochemical characteristics of the disease.
- To examine whether changes in circadian rhythm are associated with improvement in clinical and biological disease activity
Study design:
- A prospective cohort study. Eligible patients will be follow up for at least one year or until relapse time.
- Setting: prospectively collect clinical, behavioral, dietary and environmental data of IBD patients currently declared in an endoscopic remission according to the criteria in Israel. Data will be collected according to a uniform standardized protocol specifically adapted to the needs of the study. The team will include members of the IBD clinic at the Tel Aviv Medical Center, run by Dr. Nitsan Maharshak.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- 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)
Key exclusion criteria (6 listed)
- • Inability to sign an informed consent and complete the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease exacerbation for CD patients
Time frame: follow up for at least one year or until relapse time or until 2 years of follow up
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:
Disease exacerbation in UC patients
Time frame: follow up for at least one year or until relapse time or until 2 years of follow up
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:
Disease exacerbation in UC-Pouch patients
Time frame: follow up for at least one year or until relapse time or until 2 years of follow up
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:
3 secondary outcomes
nutritional factors as a risk of disease exacerbation
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
Time frame: follow up for at least one year or until relapse time
o Stress as a risk factor for relapse
Time frame: follow up for at least one year or until relapse time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Ulcerative Colitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitsan Maharshak, Professor (972-36972428, nitsanm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease exacerbation for CD patients (time frame: follow up for at least one year or until relapse time or until 2 years of follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.