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IBD Registry in a Sub-Saharan African Population

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliBado kuajiri
Wadhamini
University of Zimbabwe
Washirika
IBDnet
University of Bern

Maneno muhimu

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho: 11/30/2019
Iliyowasilishwa Kwanza: 11/24/2019
Uandikishaji uliokadiriwa Uliwasilishwa: 11/24/2019
Iliyotumwa Kwanza: 11/25/2019
Sasisho la Mwisho Liliwasilishwa: 12/01/2019
Sasisho la Mwisho Lilichapishwa: 12/03/2019
Tarehe halisi ya kuanza kwa masomo: 01/01/2020
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 12/30/2021
Tarehe ya Kukamilisha Utafiti: 12/30/2025

Hali au ugonjwa

Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease

Uingiliaji / matibabu

Other: No intervention

Awamu

-

Vikundi vya Arm

MkonoUingiliaji / matibabu
Cases
Cases of inflammatory bowel disease
Controls
Two controls per case. 1. Sibling or other second degree relative of similar age. 2. neighbourhood control matched for age

Vigezo vya Kustahiki

Jinsia Inastahiki KujifunzaAll
Njia ya sampuliNon-Probability Sample
Hupokea Wajitolea wa AfyaNdio
Vigezo

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

Matokeo

Hatua za Matokeo ya Msingi

1. Demographic and phenotypic features of inflammatory bowel disease [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

Hatua za Matokeo ya Sekondari

1. Risk factors of inflammatory bowel disease in Zimbabwe [Two years]

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.

2. Dietary risk factors of inflammatory bowel disease in Zimbabwe [Two years]

Odds ratios for dietary patterns derived from a validated semi-quantitative food frequency questionnaire administered to cases and controls will be calculated.

3. Incidence and prevalence of inflammatory bowel disease in Zimbabwe [Three years]

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.

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