Advanced Therapy Registry of IBD Patients
Understanding the Importance of the Microbiome and Metabolome in IBD Patients
1 other identifier
observational
1,000
1 country
1
Brief Summary
The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2019
CompletedFirst Submitted
Initial submission to the registry
June 27, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2025
CompletedJuly 22, 2022
July 1, 2022
5.3 years
June 27, 2021
July 21, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
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.
2019-2024
Biologic response as determined by a decrease in C-Reactive Protein (CRP), fecal calprotectin >10% from baseline.
2019-2024
Improvement in patient quality of sleep score
as determined by a decrease of \>10% from baseline.
2019-2024
Improvement in patient quality of life score
as determined by a decrease of \>10% from baseline.
2019-2024
Improvement in stress score
2019-2024
Clinical response as determined by the Harvie Bradshaw Index (HBI)>3 points among crohn's patients
2019-2024
Clinical response as determined by the Simple Clinical Colitis Activity Index (SCCAI)>3 points among UC patients
2019-2024
Eligibility Criteria
The investigators aim to collect data from a total of 1000 patients.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Clinical Research and Development Department
Study Record Dates
First Submitted
June 27, 2021
First Posted
August 10, 2021
Study Start
February 28, 2019
Primary Completion
June 27, 2024
Study Completion
June 27, 2025
Last Updated
July 22, 2022
Record last verified: 2022-07