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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-10

Study Completion Date

2018-07-10

Brief Summary

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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)

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Detailed Description

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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

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IBS - Irritable Bowel Syndrome General Population

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IBS & general population

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.

completion of self-reported questionnaires

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No