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RecruitingNCT04998084Updated Jul 22, 2022

Advanced Therapy Registry of IBD Patients

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 75 Years. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Feb 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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:

  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.

02

Conditions studied

  • Crohn Disease
  • Ulcerative Colitis
  • Pouchitis
03

In context

Crohn Disease

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 →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.

Browse Tel-Aviv Sourasky Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The investigators aim to collect data from a total of 1000 patients.

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.

Inclusion criteria

Patients who belong to one of the following sub-groups:

  1. Newly diagnosed (\<1 years), therapy naïve IBD and pouchitis patients
  2. IBD patients in complete remission (treated or untreated with biologics)
  3. Patients (with and without IBD) scheduled to commence a biological therapy

Exclusion criteria

Exclusion Criteria:

  1. Age≤18 years
  2. Inability to sign an
  3. Abdominal surgery during the previous 3 months
  4. Systemic antibiotic therapy in the previous 4 weeks
  5. Severe systemic disease such as kidney, liver, neurologic, cardio-vascular disease
  6. Primary sclerosing cholangitis
  7. Pregnancy at recruitment
  8. Cancer within the previous 5 years excluding local NMSC
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

  2. Biologic response as determined by a decrease in C-Reactive Protein (CRP), fecal calprotectin >10% from baseline.

    Time frame: 2019-2024

  3. Improvement in patient quality of sleep score

    as determined by a decrease of \>10% from baseline.

    Time frame: 2019-2024

  4. Improvement in patient quality of life score

    as determined by a decrease of \>10% from baseline.

    Time frame: 2019-2024

  5. Improvement in stress score

    Time frame: 2019-2024

  6. Clinical response as determined by the Harvie Bradshaw Index (HBI)>3 points among crohn's patients

    Time frame: 2019-2024

  7. Clinical response as determined by the Simple Clinical Colitis Activity Index (SCCAI)>3 points among UC patients

    Time frame: 2019-2024

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2019 (actual). Primary completion is estimated for Jun 2024, 63 months after the start.

Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's planned 63 months is above that.

Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2021
First posted
Aug 10, 2021
StartActual
Feb 28, 2019
Primary completionEst.
Jun 27, 2024
CompletionEst.
Jun 27, 2025
Last update
Jul 22, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04998084
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Eli Sprecher, MD (Director of Clinical Research and Development Department, Tel-Aviv Sourasky Medical Center) — Principal investigator
First posted
Aug 10, 2021
Start date
Feb 28, 2019
Primary completion
Jun 27, 2024 (estimated)
Completion
Jun 27, 2025 (estimated)
Last update
Jul 22, 2022

Study contacts

Naomi fliss, Dr.
Contact
naomifl@tlvmc.gov.il
972-3-6947305

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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