Understanding the Importance of the Microbiome and Metabolome in IBD Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Eli Sprecher, MD
Director of Clinical Research and Development Department
Tel-Aviv Sourasky Medical Center