IBD Registry in a Sub-Saharan African Population

Recruiting

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Ulcerative Colitis
• Interventions: Other: No intervention

• Registration Number: NCT04178408
• Lead Sponsor: University of Zimbabwe

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.

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2021-01-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	No intervention	Cases of inflammatory bowel disease
Controls	No intervention	Two controls per case. 1. Sibling or other second degree relative of similar age. 2. neighbourhood control matched for age

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Parirenyatwa Hospital; 🇿🇼 Harare, Zimbabwe