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

Paris Diderot University

Status: Completed

Conditions: IBS - Irritable Bowel Syndrome; General Population

Treatments: Other: completion of self-reported questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT03002584

IGQ

Details and patient eligibility

About

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)

Full 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)

Enrollment: 300 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

All (subjects with IBS diagnosis and general population):

• Complaining of gas-related symptoms (GRS) of a certain severity level: subjects with IBS diagnosis and general population need to report a score of 4 or greater on at least one symptom on the symptom screening tool
• Cognitive and linguistic capability to complete several self-questionnaires
• BMI > 18.5 and < 30.0 kg/m2
• Agreement of the subject to participate in the study

Subjects with IBS diagnosis:

• IBS diagnosis using Rome III diagnostic criteria for Functional Gastrointestinal Disorders (21)
• IBS severity: IBS-SSS score of 75 to 300

General population:

• Subjects not fulfilling IBS Rome III criteria
• Regular stool frequency (i.e., between 3 and 21 bowel movements per week)

Exclusion criteria

All (subjects with IBS diagnosis and general population):

• Recent (2 last weeks) change in diet or intake of potentially flatulogenic compounds (fiber, lactulose)
• Organic gastrointestinal disease
• Other functional gastrointestinal disorder as defined by Rome III criteria
• Any severe and progressive disease (e.g. depression, cancer, uncontrolled diabetes, rheumatoid arthritis...)
• Any severe psychiatric disorder (e.g. acute episode of schizophrenia or bipolar disorder...)
• Pregnant women
• Being under the direct hierarchy of the investigatorBelonging to the site's staff team

General population:

• Treatment for diarrhea or constipation including lactulose

Trial design

300 participants in 1 patient group

IBS & general population

Description:

The participants will be given the IGQ questionnaire to complete as well as other 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.

Treatment:

Other: completion of self-reported questionnaires