IBD Registry in a Sub-Saharan African Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Zimbabwe
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Cases
Any patient with confirmed inflammatory bowel disease
Onset of disease ≥3 months ago.
Controls
Disqualifiers
Cases
Controls
Suspected inflammatory bowel disease
Unexplained gastrointestinal symptoms including diarrhoea, vomiting, chronic abdominal pain, weight loss, rectal bleeding, and recent change in bowel habit.
Trial population
Cases of inflammatory bowel disease and healthy controls
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cases1 intervention
Group B: Controls1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
one yearSecondary outcomes
1
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.
Time frame
Two years2
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.
Time frame
Two years3
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.
Time frame
Three yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov