Inflammatory bowel disease in sub-Saharan Africa: a protocol of a prospective registry with a nested case-control study.
Leolin Katsidzira, Wisdom F Mudombi, Rudo Makunike-Mutasa...
https://pubmed.ncbi.nlm.nih.gov/33371021Actively Recruiting
All Genders
Healthy Volunteers
ID04178408
Registry to Study the Incidence, Phenotype, Risk Factors, and Clinical Course of Inflammatory Bowel Disease in Zimbabwe
Led by University of Zimbabwe · Updated on 2024-07-11
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Zimbabwe
Lead Sponsor
S
Swiss IBDnet
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are establishing a prospective registry to study patients diagnosed with inflammatory bowel disease (IBD) at a hospital in Harare, Zimbabwe. This observational study will gather data on disease types, progression, and treatment, while also biobanking stool samples and germline DNA. A nested case-control study will recruit one relative and one neighbor of each patient to explore risk factors for IBD in this population. The study will enroll confirmed IBD cases from various clinics and hospitals, along with two controls per case: a sibling or cousin of similar age and a neighbor matched by age. Data collection will include demographic and clinical information at baseline, six months, and annually afterward. Participants will complete questionnaires about IBD risk factors and diet. Biological samples will be stored for future analysis. Participants will undergo regular assessments including clinical data collection and questionnaire responses over time. The research team will analyze demographic and disease characteristics, estimate IBD incidence in Harare, and study risk factors using statistical methods. The study plans preliminary analysis after recruiting at least 100 patients and will continue monitoring participants for several years to gather comprehensive information about IBD in this population.
CONDITIONS
Brief Title
IBD Registry in a Sub-Saharan African Population
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of inflammatory bowel disease with disease onset at least 3 months ago (cases)
- Adults aged 18 years or older for controls
- Controls must be a sibling or cousin (2nd degree relative) and a neighbor matched by age
You will not qualify if you...
- Controls with suspected inflammatory bowel disease
- Controls with unexplained gastrointestinal symptoms such as diarrhea, vomiting, chronic abdominal pain, weight loss, rectal bleeding, or recent bowel habit changes
- Controls with previous unexplained gastrointestinal surgery
- Cases have no exclusion criteria specified for this study period or analysis phase except age restriction for case-control analysis (under 18 excluded from case-control analysis only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 3 years
Participants are observed and assessed through data collection for demographic, clinical, dietary, and risk factors related to inflammatory bowel disease.
Baseline visit, follow-up at 6 months, and annual visits thereafter
Trial Site Locations
Total: 1 location
1
Parirenyatwa Hospital
Harare, Zimbabwe
Actively Recruiting
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Research Team
L
Leolin Katsidzira, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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