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

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

Sponsors

Lead sponsor: University Paris 7 - Denis Diderot

Collaborator: EA 7334, Patient-Centered Outcomes Research
University of Manchester
Hospital Vall d'Hebron
Hôpital Louis Mourier

Source University Paris 7 - Denis Diderot
Brief 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)

Overall Status Completed
Start Date February 10, 2017
Completion Date July 10, 2018
Primary Completion Date April 30, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Psychometric validation of the IGQ cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants
Secondary Outcome
Measure Time Frame
Electronic version of the IGQ During test-retest within an interval of 7 days
Enrollment 300
Condition
Intervention

Intervention type: Other

Intervention name: completion of self-reported questionnaires

Description: 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

Arm group label: IBS & general population

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Location
facility
Hopital Louis Mourier | Colombes, 92700, France
Centro de salud Chafarinas | Barcelona, 08033, Spain
Horta, Hospital Universitari Vall d'Hebron | Barcelona, 08035, Spain
Centre Mèdic Sant Andreu | Barcelona, 08740, Spain
Wythenshawe Hospital | Manchester, M23 9LT, United Kingdom
Location Countries

France

Spain

United Kingdom

Verification Date

February 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University Paris 7 - Denis Diderot

Investigator full name: Olivier CHASSANY

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 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.

Acronym PRoVING
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov