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

February 15, 2019 updated by: Olivier CHASSANY, University Paris 7 - Denis Diderot

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During test-retest within an interval of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Paris 7 - Denis Diderot

Collaborators

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

Investigators

  • Study Chair: Olivier Chassany, MD, PhD, EA 7334, University Paris-Diderot, Paris
  • Principal Investigator: Peter Whorwell, MD, PhD, university of Manchester, Manchester
  • Principal Investigator: Fernando Azpiroz, MD, PhD, Hospital Vall D'Hebrón, Barcelona
  • Principal Investigator: Benoit Coffin, MD, PhD, Hopital Louis Mourier, Colombes
  • Study Director: Martin Duracinsky, MD, PhD, EA 7334, University Paris-Diderot, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2017

Primary Completion (ACTUAL)

April 30, 2018

Study Completion (ACTUAL)

July 10, 2018

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (ESTIMATE)

December 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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