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NCT Number: NCT04178408

IBD Registry in a Sub-Saharan African Population

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Demographic and phenotypic features of inflammatory bowel disease

    Time frame: 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 outcomes

  1. Risk factors of inflammatory bowel disease in Zimbabwe

    Time frame: 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.

  2. Dietary risk factors of inflammatory bowel disease in Zimbabwe

    Time frame: Two years

    Odds ratios for dietary patterns derived from a validated semi-quantitative food frequency questionnaire administered to cases and controls will be calculated.

  3. Incidence and prevalence of inflammatory bowel disease in Zimbabwe

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leolin Katsidzira, MD

CONTACT

[email protected]

+263 77 2377 416

Sponsors and collaborators

Lead sponsor

University of Zimbabwe

Other

Collaborators

  • Swiss IBDnet
  • University of Bern

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2019
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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