An observational study in Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease, sponsored by University of Zimbabwe. Recruiting at 1 site in Zimbabwe. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by University of Zimbabwe · Observational
The investigators intend to establish a prospective registry of patients diagnosed with inflammatory bowel disease at Parirenyatwa hospital in Harare, Zimbabwe. The study will periodically collect data on disease phenotype, disease course, and clinical management, and will biobank stool specimens and germline DNA. One relative, and an individual from the same neighbourhood will be also be recruited for a nested case-control study into risk factors of inflammatory bowel disease in this population.
A prospective observational registry with a nested case-control study will be established at a gastrointestinal outpatient's clinic at a tertiary care hospital in Harare, Zimbabwe. The registry will recruit confirmed cases of inflammatory bowel disease from the clinic, other hospitals within and outside Harare, and from private practitioners. Two controls, a sibling or cousin, and an individual living in the same neighbourhood will also be recruited for each case. Demographic and clinical data will be obtained for all cases at baseline, after 6 months and annually thereafter. A questionnaire adapted from the International Organisation of IBD for risk factors of inflammatory bowel disease, and a food frequency questionnaire will be administered to all participants. Stool specimens, and germline DNA from peripheral blood will be biobanked in the Department of Medicine at the University of Zimbabwe. Preliminary data analysis will be carried out after at least 100 patients have been recruited. Descriptive statistics will be used to summarise data on demographic and phenotypic characteristics of inflammatory bowel disease, and incidence will be estimated for Harare. Risk factors for inflammatory bowel disease will be analysed using conditional logistic regression.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 100 is below the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →University of Zimbabwe is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cases of inflammatory bowel disease and healthy controls
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.
Cases
Controls
Exclusion Criteria:
Cases
Controls
Cases of inflammatory bowel disease
Other: No intervention
Two controls per case. 1. Sibling or other second degree relative of similar age. 2. neighbourhood control matched for age
Other: No intervention
No intervention
Demographic and phenotypic features of inflammatory bowel disease
Data on demographic (age, gender, ethnicity) and phenotypic (Crohn's disease versus ulcerative colitis, location, severity, extra-intestinal manifestations etc) will be collected using a standardised case report report forms
Time frame: one year
Risk factors of inflammatory bowel disease in Zimbabwe
Odds ratios of risk factors such as exposure to antibiotics, smoking, markers of hygiene such as sanitary conditions, etc) collected using the using the International Organisation for the Study of Inflammatory bowel disease (IOBD) risk factor questionnaire will be calculated.
Time frame: Two years
Dietary risk factors of inflammatory bowel disease in Zimbabwe
Odds ratios for dietary patterns derived from a validated semi-quantitative food frequency questionnaire administered to cases and controls will be calculated.
Time frame: Two years
Incidence and prevalence of inflammatory bowel disease in Zimbabwe
The incidence and prevalence will be estimated using the annual number of new cases, and the total number of cases in Harare respectively and the total population of the city as the denominator.
Time frame: Three years
Plan to share: Undecided
Started Jan 2021 (actual). Primary completion is estimated for Dec 2025, 59 months after the start.
Of 243 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 132. This study's planned 59 months is above that.
Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
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University of Zimbabwe