IBD Registry in a Sub-Saharan African Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-02

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Cases of inflammatory bowel disease

No intervention

Intervention Type OTHER

No intervention

Controls

Two controls per case. 1. Sibling or other second degree relative of similar age. 2. neighbourhood control matched for age

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes