Clinical trial NCT04178408: IBD Registry in a Sub-Saharan African Population
Official title: Registry to Study the Incidence, Phenotype, Risk Factors and Clinical Course of Inflammatory Bowel Disease in Zimbabwe
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Lead sponsor: University of Zimbabwe
Sponsor class: OTHER
Collaborators: name: Swiss IBDnet
name: University of Bern
First posted: 2019-11-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases of inflammatory bowel disease and healthy controls

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic and phenotypic features of inflammatory bowel disease
timeFrame: one year
Secondary outcomes:
measure: Risk factors of inflammatory bowel disease in Zimbabwe
timeFrame: Two years
measure: Dietary risk factors of inflammatory bowel disease in Zimbabwe
timeFrame: Two years
measure: Incidence and prevalence of inflammatory bowel disease in Zimbabwe
timeFrame: Three years
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Parirenyatwa Hospital
Study officials:
affiliation: University of Zimbabwe
name: Leolin Katsidzira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.