IBS - Irritable Bowel Syndrome Clinical Trial
Official title:
International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ)
in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both
complaining of Gas-Related Symptoms (GRS).
IGQ has been developed previously simultaneously in UK English, French and Spanish through
qualitative research with subject interviews. The conceptual framework of the IGQ assesses
both GRS and their impact on daily life. Similar concepts were identified for both subjects
with IBS diagnosis and general population and complaining of gas-related symptoms.
The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17
items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26
items)
Observational (non-interventional) study with a cross-sectional part for a subset of adult
subjects with a single IGQ completion and a longitudinal cross-over part for a subset of
subjects with test-retest IGQ completion for validation of electronic version of IGQ.
300 eligible subjects (100 in each of the 3 countries: France, UK & Spain):
- 180 with IBS diagnosis (60% of recruited subjects)
- 120 from General population (40% of recruited subjects)
;
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