Skip to main content
OpenTrials
Completed

NCT Number: NCT03002584

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

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)

Completed

Looking for future studies?

Notify Me

Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

completion of self-reported questionnaires

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

Primary outcomes

  1. Psychometric validation of the IGQ

    Time frame: cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants

    Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire

Secondary outcomes

  1. Electronic version of the IGQ

    Time frame: During test-retest within an interval of 7 days

    Comparison of scores between paper and electronic version of IGQ

Sponsors and collaborators

Lead sponsor

University Paris 7 - Denis Diderot

Other

Collaborators

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

Registry information

Acronym: PRoVING

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2016
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.