Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Swiss IBDnet
University of Bern
University of Zimbabwe
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Cases 1. Any patient with confirmed inflammatory bowel disease 2. Onset of disease ≥3 months ago. * Controls 1. Age ≥ 18 years (NB - cases younger than 18 will be excluded from case-control analysis 2. One sibling or cousin (2nd degree) and one neighbourhood control.
Exclusion criteria
* Cases 1\. None * Controls 1. Suspected inflammatory bowel disease 2. Unexplained gastrointestinal symptoms including diarrhoea, vomiting, chronic abdominal pain, weight loss, rectal bleeding, and recent change in bowel habit. 3. Previous unexplained gastrointestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographic and phenotypic features of inflammatory bowel disease | one year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk factors of inflammatory bowel disease in Zimbabwe | Two years | 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. |
| Dietary risk factors of inflammatory bowel disease in Zimbabwe | Two years | Odds ratios for dietary patterns derived from a validated semi-quantitative food frequency questionnaire administered to cases and controls will be calculated. |
| Incidence and prevalence of inflammatory bowel disease in Zimbabwe | Three years | 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. |
Countries
Zimbabwe
Contacts
Primary ContactLeolin Katsidzira, MD
Outcome results
None listed