IBD Registry in a Sub-Saharan African Population

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178408
• Other study ID #: IBDZIM
• Status: Recruiting
• Start date: January 2, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2022
• Source: University of Zimbabwe
• Contact: Leolin Katsidzira, MD
• Phone: +263 77 2377 416
• Email: lkatsidzira[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Zimbabwe	Parirenyatwa Hospital	Harare

Sponsors (3)

Lead Sponsor	Collaborator
University of Zimbabwe	IBDnet, University of Bern

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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