UnknownNot Applicable

Advanced Therapy Registry of IBD Patients

Israel1,000 participantsStarted 2019-02-28

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

What they're measuring

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.

Timeframe: 2019-2024

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

Timeframe: 2019-2024

Improvement in patient quality of sleep score

Timeframe: 2019-2024

Improvement in patient quality of life score

Timeframe: 2019-2024

Improvement in stress score

Timeframe: 2019-2024

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

Timeframe: 2019-2024

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

Timeframe: 2019-2024

Trial details

NCT IDNCT04998084

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-06-27

Contact for this trial

Naomi fliss, Dr.

972-3-6947305 naomifl@tlvmc.gov.il

View on ClinicalTrials.gov More Crohn Disease trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

What they're measuring

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.

Timeframe: 2019-2024

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

Timeframe: 2019-2024

Improvement in patient quality of sleep score

Timeframe: 2019-2024

Improvement in patient quality of life score

Timeframe: 2019-2024

Improvement in stress score

Timeframe: 2019-2024

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

Timeframe: 2019-2024

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

Timeframe: 2019-2024