IBD Registry in a Sub-Saharan African Population

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Leolin Katsidzira, MD; Phone Number: +263 77 2377 416; Email: lkatsidzira@hotmail.com

Study Locations

• Zimbabwe
  • Harare, Zimbabwe
    • Recruiting
    • Parirenyatwa Hospital
    • Contact: Leolin Katsidzira, MD; Phone Number: +263772377416; Email: lkatsidzira@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases of inflammatory bowel disease and healthy controls

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zimbabwe
• Collaborators: University of Bern; IBDnet
• Investigators: Principal Investigator: Leolin Katsidzira, MD, University of Zimbabwe

Publications and helpful links

General Publications

• Katsidzira L, Mudombi WF, Makunike-Mutasa R, Yilmaz B, Blank A, Rogler G, Macpherson A, Vavricka S, Gangaidzo I, Misselwitz B. Inflammatory bowel disease in sub-Saharan Africa: a protocol of a prospective registry with a nested case-control study. BMJ Open. 2020 Dec 22;10(12):e039456. doi: 10.1136/bmjopen-2020-039456.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: IBDZIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No