Crohn DiseaseNCT04998084
Advanced Therapy Registry of IBD Patients
An observational study of Crohn Disease and Ulcerative Colitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Pouchitis
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Feb 2019to 27 Jun 2025
- 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 75 years
- All sexes
- Adult, Older adult
Study population: The investigators aim to collect data from a total of 1000 patients.
Who may be able to join
- Patients who belong to one of the following sub-groups:
- Newly diagnosed (<1 years), therapy naïve IBD and pouchitis patients
- IBD patients in complete remission (treated or untreated with biologics)
- Patients (with and without IBD) scheduled to commence a biological therapy
Who cannot join
- Age≤18 years
- Inability to sign an informed consent
- Abdominal surgery during the previous 3 months
- Systemic antibiotic therapy in the previous 4 weeks
- Severe systemic disease such as kidney, liver, neurologic, cardio-vascular disease
- Primary sclerosing cholangitis
- Pregnancy at recruitment
- Cancer within the previous 5 years excluding local NMSC
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
NAOMI FLISS, Dr., 972-3-6947305, naomifl@tlvmc.gov.il
About this study
Official title: Understanding the Importance of the Microbiome and Metabolome in IBD Patients
The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.
Read the detailed description
The study is aim to detect common microbial profiles and metabolic pathways in patients belonging to the following groups:
- Therapy naïve newly diagnosed Crohn's disease (CD), ulcerative colitis (UC) and pouchitis patients. Studying this group of patients will enable the detection of microbial profiles associated with disease onset.
- Patients planned to commence biological therapy (with or without IBD). Studying this group of patients will enable the detection of microbial profiles associated with response to biological therapy.
- IBD patients in complete remission (treated or untreated with biologics). Following this group of patients will enable the detection of microbial profiles associated with disease exacerbation.
Methods:
Study design: A prospective cohort study. Setting: The investigators will prospectively collect clinical, behavioral and environmental data of patients participating in the study. Data will be collected according to a uniform standardized protocol specifically adapted to the needs of the study and shared between the collaborators.
Study population: Eligible patients, who sign an informed consent form and answer 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 coordinators.
sample size: sample size was estimated according to clinical capabilities of the researcher. We aim to collect data from a total of 1000 patients.
Schedule: Data will be collected between the years 2019-2024.
Study plan:
Patient and disease characteristics At baseline, demographic characteristics, medical history and specifically IBD phenotype, severity, extent and location, disease duration, previous medicinal treatment will be documented. Baseline and follow-up study visits which will include biological sample collection and questionnaires.
Patients will be asked to complete questionnaires to account for their lifestyle, sleep, quality of life and disease related symptoms and outcomes. Physician global assessment (PGA), disease severity using clinical scores (HBI and SCCAI scores for CD and UC patients) and biochemical data (CRP, fecal calprotectin) will be documented.
- 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.
Clinical response as determined by a decrease in Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) decrease of ≥3 points among CD and UC patients respectively.
Measured: 2019-2024
Biologic response as determined by a decrease in C-Reactive Protein (CRP), fecal calprotectin >10% from baseline.
Measured: 2019-2024
Improvement in patient quality of sleep score
as determined by a decrease of >10% from baseline.
Measured: 2019-2024
Improvement in patient quality of life score
as determined by a decrease of >10% from baseline.
Measured: 2019-2024
Improvement in stress score
Measured: 2019-2024
Clinical response as determined by the Harvie Bradshaw Index (HBI)>3 points among crohn's patients
Measured: 2019-2024
Clinical response as determined by the Simple Clinical Colitis Activity Index (SCCAI)>3 points among UC patients
Measured: 2019-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start28 Feb 2019
- Primary completion27 Jun 2024 (estimated)
- Study completion27 Jun 2025 (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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998084
- Sponsor's protocol ID
- 0162-19-TLV
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Importance of the Microbiome and Metabolome in IBD Patients
- ClinicalTrials.gov ID
- NCT04998084
- Acronym / sponsor ID
- 0162-19-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
- 28 Feb 2019 (actual)
- Primary completion
- 27 Jun 2024 (estimated)
- Study completion
- 27 Jun 2025 (estimated)
- First posted
- 10 Aug 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 study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.
Detailed description
The study is aim to detect common microbial profiles and metabolic pathways in patients belonging to the following groups:
- Therapy naïve newly diagnosed Crohn's disease (CD), ulcerative colitis (UC) and pouchitis patients. Studying this group of patients will enable the detection of microbial profiles associated with disease onset.
- Patients planned to commence biological therapy (with or without IBD). Studying this group of patients will enable the detection of microbial profiles associated with response to biological therapy.
- IBD patients in complete remission (treated or untreated with biologics). Following this group of patients will enable the detection of microbial profiles associated with disease exacerbation.
Methods:
Study design: A prospective cohort study. Setting: The investigators will prospectively collect clinical, behavioral and environmental data of patients participating in the study. Data will be collected according to a uniform standardized protocol specifically adapted to the needs of the study and shared between the collaborators.
Study population: Eligible patients, who sign an informed consent form and answer 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 coordinators.
sample size: sample size was estimated according to clinical capabilities of the researcher. We aim to collect data from a total of 1000 patients.
Schedule: Data will be collected between the years 2019-2024.
Study plan:
Patient and disease characteristics At baseline, demographic characteristics, medical history and specifically IBD phenotype, severity, extent and location, disease duration, previous medicinal treatment will be documented. Baseline and follow-up study visits which will include biological sample collection and questionnaires.
Patients will be asked to complete questionnaires to account for their lifestyle, sleep, quality of life and disease related symptoms and outcomes. Physician global assessment (PGA), disease severity using clinical scores (HBI and SCCAI scores for CD and UC patients) and biochemical data (CRP, fecal calprotectin) will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to collect data from a total of 1000 patients.
Key inclusion criteria (4 listed)
- Newly diagnosed (<1 years), therapy naïve IBD and pouchitis patients
- IBD patients in complete remission (treated or untreated with biologics)
- Patients (with and without IBD) scheduled to commence a biological therapy
Key exclusion criteria (8 listed)
- Age≤18 years
- Inability to sign an informed consent
- Abdominal surgery during the previous 3 months
- Systemic antibiotic therapy in the previous 4 weeks
- Severe systemic disease such as kidney, liver, neurologic, cardio-vascular disease
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
Clinical response as determined by a decrease in Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) decrease of ≥3 points among CD and UC patients respectively.
Time frame: 2019-2024
Biologic response as determined by a decrease in C-Reactive Protein (CRP), fecal calprotectin >10% from baseline.
Time frame: 2019-2024
Improvement in patient quality of sleep score
Time frame: 2019-2024
as determined by a decrease of >10% from baseline.
Improvement in patient quality of life score
Time frame: 2019-2024
as determined by a decrease of >10% from baseline.
Improvement in stress score
Time frame: 2019-2024
Clinical response as determined by the Harvie Bradshaw Index (HBI)>3 points among crohn's patients
Time frame: 2019-2024
Clinical response as determined by the Simple Clinical Colitis Activity Index (SCCAI)>3 points among UC patients
Time frame: 2019-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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 4 inclusion and 8 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 22 Jul 2022. 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 Naomi fliss, Dr. (972-3-6947305, naomifl@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response as determined by a decrease in Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) decrease of ≥3 points among CD and UC patients respectively. (time frame: 2019-2024). The study lists 7 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 22 Jul 2022.