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

IBS - Irritable Bowel Syndrome Clinical Trial

— PRoVING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002584
• Other study ID #: IGQ
• Status: Completed
• Start date: February 10, 2017
• Est. completion date: July 10, 2018

Study information

• Verified date: February 2019
• Source: University Paris 7 - Denis Diderot
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 10, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• General Population
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Hopital Louis Mourier	Colombes
Spain	Centre Mèdic Sant Andreu	Barcelona
Spain	Centro de salud Chafarinas	Barcelona
Spain	Horta, Hospital Universitari Vall d'Hebron	Barcelona
United Kingdom	Wythenshawe Hospital	Manchester

Sponsors (5)

Lead Sponsor	Collaborator
University Paris 7 - Denis Diderot	EA 7334, Patient-Centered Outcomes Research, Hôpital Louis Mourier, Hospital Vall d'Hebron, University of Manchester

Countries where clinical trial is conducted

France,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric validation of the IGQ	Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire	cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants
Secondary	Electronic version of the IGQ	Comparison of scores between paper and electronic version of IGQ	During test-retest within an interval of 7 days

External Links

•   Results of the qualitative analysis