IBD Registry in a Sub-Saharan African Population

NCT04178408 | Recruiting

• 1 other identifier: IBDZIM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Outcome Measures

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

  one year

Secondary Outcomes (3)

• Risk factors of inflammatory bowel disease in Zimbabwe

  Two years

• Dietary risk factors of inflammatory bowel disease in Zimbabwe

  Two years

• Incidence and prevalence of inflammatory bowel disease in Zimbabwe

  Three years

Study Arms (2)

Cases

Cases of inflammatory bowel disease

Other: 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

Interventions

No intervention OTHER

No intervention

Cases; Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases of inflammatory bowel disease and healthy controls

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zimbabwe: lead
• Swiss IBDnet: collaborator
• University of Bern: collaborator

Study Sites (1)

Parirenyatwa Hospital

Harare, Zimbabwe

RECRUITING

Related Publications (1)

• 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.

  PMID: 33371021 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

stool specimens, and germline DNA from peripheral blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Leolin Katsidzira, MD

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leolin Katsidzira, MD

CONTACT

+263 77 2377 416; lkatsidzira@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Study Start: January 2, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

ZI (1)