IBD Registry in a Sub-Saharan African Population

University of Zimbabwe

Status

Enrolling

Conditions

Ulcerative Colitis

Inflammatory Bowel Diseases

Crohn Disease

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04178408

IBDZIM

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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