Clinical trial NCT03002584: International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
Official title: International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBS - Irritable Bowel Syndrome
General Population
Keywords: IBS, population
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
Collaborators: name: EA 7334, Patient-Centered Outcomes Research
name: University of Manchester
name: Hospital Vall d'Hebron
name: Hôpital Louis Mourier
First posted: 2016-12-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)

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)

Eligibility 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

Primary outcomes:
measure: Psychometric validation of the IGQ
timeFrame: cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants
Secondary outcomes:
measure: Electronic version of the IGQ
timeFrame: During test-retest within an interval of 7 days
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Barcelona
country: Spain
facility: Centro de salud Chafarinas
city: Barcelona
country: Spain
facility: Horta, Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Centre Mèdic Sant Andreu
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: EA 7334, University Paris-Diderot, Paris
name: Olivier Chassany, MD, PhD
role: STUDY_CHAIR
affiliation: university of Manchester, Manchester
name: Peter Whorwell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebron, Barcelona
name: Fernando Azpiroz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Louis Mourier, Colombes
name: Benoit Coffin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: EA 7334, University Paris-Diderot, Paris
name: Martin Duracinsky, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Chassany O, Tugaut B, Marrel A, Guyonnet D, Arbuckle R, Duracinsky M, Whorwell PJ, Azpiroz F. The Intestinal Gas Questionnaire: development of a new instrument for measuring gas-related symptoms and their impact on daily life. Neurogastroenterol Motil. 2015 Jun;27(6):885-98. doi: 10.1111/nmo.12565. Epub 2015 Apr 6.