Inflammatory Bowel DiseasesNCT04178408
IBD Registry in a Sub-Saharan African Population
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Zimbabwe at 1 site in Zimbabwe.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- How many people
- 100 participants
- Where
- 1 siteZimbabwe
- Study dates
- 2 Jan 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cases of inflammatory bowel disease and healthy controls
Who may be able to join
- 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.
Who cannot join
- Cases
- 1. 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
Trial locations and contacts
1 site in 1 country.
Zimbabwe1 site, 1 recruiting
- Recruiting
Parirenyatwa Hospital
Harare
Leolin Katsidzira, MD, +263772377416, lkatsidzira@hotmail.com
About this study
Official title: Registry to Study the Incidence, Phenotype, Risk Factors and Clinical Course of Inflammatory Bowel Disease in Zimbabwe
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.
Read the 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.
- Being tested
- No intervention
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases of inflammatory bowel disease Receives: Other: No intervention | |
| Controls | Two controls per case. 1. Sibling or other second degree relative of similar age. 2. neighbourhood control matched for age Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (3)
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start2 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss IBDnet, University of Bern
- Responsible party
- Sponsor
- Investigators
- Leolin Katsidzira, MD, Principal investigator, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178408
- Sponsor's protocol ID
- IBDZIM
- Status last verified
- Jul 2024
- First submitted
- 25 Nov 2019
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33371021
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Study the Incidence, Phenotype, Risk Factors and Clinical Course of Inflammatory Bowel Disease in Zimbabwe
- ClinicalTrials.gov ID
- NCT04178408
- Acronym / sponsor ID
- IBDZIM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- Swiss IBDnet, University of Bern
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: No interventionCases of inflammatory bowel disease |
| Controls | – | Other: No interventionTwo controls per case. 1. Sibling or other second degree relative of similar age. 2. neighbourhood control matched for age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases of inflammatory bowel disease and healthy controls
Key inclusion criteria (6 listed)
- Cases
- Controls
Key exclusion criteria (6 listed)
- Cases
- 1. None
- Controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Cases, Controls |
Primary outcome
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
3 secondary outcomes
Risk factors of inflammatory bowel disease in Zimbabwe
Time frame: Two years
Dietary risk factors of inflammatory bowel disease in Zimbabwe
Time frame: Two years
Incidence and prevalence of inflammatory bowel disease in Zimbabwe
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 33371021Katsidzira 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leolin Katsidzira, MD principal investigator
University of Zimbabwe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Zimbabwe at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leolin Katsidzira, MD (+263 77 2377 416, lkatsidzira@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and phenotypic features of inflammatory bowel disease (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.