IBD Registry in a Sub-Saharan African Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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Registry to Study the Incidence, Phenotype, Risk Factors and Clinical Course of Inflammatory Bowel Disease in Zimbabwe

Conditions
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Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases Any patient with confirmed inflammatory bowel disease Onset of disease ≥3 months ago. Controls Age ≥ 18 years (NB - cases younger than 18 will be excluded from case-control analysis One sibling or cousin (2nd degree) and one neighbourhood control. Exclusion Criteria: Cases 1. None Controls Suspected inflammatory bowel disease Unexplained gastrointestinal symptoms including diarrhoea, vomiting, chronic abdominal pain, weight loss, rectal bleeding, and recent change in bowel habit. Previous unexplained gastrointestinal surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Cases of inflammatory bowel disease | Other: No intervention<br>* No intervention<br>|
| Controls<br>Two controls per case. 1. Sibling or other second degree relative of similar age. 2. neighbourhood control matched for age | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Three years |