Advanced Therapy Registry of IBD Patients

  • STATUS
    Recruiting
  • End date
    Jun 27, 2025
  • participants needed
    1000
  • sponsor
    Tel-Aviv Sourasky Medical Center
Updated on 4 October 2022
remission
pouchitis

Summary

The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.

Description

The study is aim to detect common microbial profiles and metabolic pathways in patients belonging to the following groups:

  1. 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.
  2. 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.
  3. 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.

Details
Condition Crohn Disease, Ulcerative Colitis, Pouchitis
Clinical Study IdentifierNCT04998084
SponsorTel-Aviv Sourasky Medical Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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