NCT03002584

International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: University Paris 7 - Denis Diderot · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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)

Conditions

• IBS - Irritable Bowel Syndrome
• General Population

Interventions

Type	Name	Description
OTHER	completion of self-reported questionnaires	Single completion: Participants will have to complete the IGQ, the generic health status EQ-5D questionnaire, the specific FDDQL questionnaire (Functional Digestive Disorders Quality of Life). Test-retest: during the second completion within a mean 7-day interval, participants will complete the IGQ and a single global Gastro-Intestinal Well-Being scale

Timeline

• Start date: 2017-02-10
• Primary completion: 2018-04-30
• Completion: 2018-07-10
• First posted: 2016-12-26
• Last updated: 2019-02-18

Locations

5 sites across 3 countries: France, Spain, United Kingdom