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

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ClinicalTrials.gov Identifier: NCT03002584
Recruitment Status : Completed
First Posted : December 26, 2016
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
EA 7334, Patient-Centered Outcomes Research
University of Manchester
Hospital Vall d'Hebron
Hôpital Louis Mourier
Information provided by (Responsible Party):
Olivier CHASSANY, 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)


Condition or disease Intervention/treatment
IBS - Irritable Bowel Syndrome General Population Other: completion of self-reported questionnaires

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)

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : July 10, 2018

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





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002584


Locations
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France
Hopital Louis Mourier
Colombes, France, 92700
Spain
Centro de salud Chafarinas
Barcelona, Spain, 08033
Horta, Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Centre Mèdic Sant Andreu
Barcelona, Spain, 08740
United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
University Paris 7 - Denis Diderot
EA 7334, Patient-Centered Outcomes Research
University of Manchester
Hospital Vall d'Hebron
Hôpital Louis Mourier
Investigators
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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'Hebron, Barcelona
Principal Investigator: Benoit Coffin, MD, PhD Hopital Louis Mourier, Colombes
Study Director: Martin Duracinsky, MD, PhD EA 7334, University Paris-Diderot, Paris

Additional Information:
Publications:
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Responsible Party: Olivier CHASSANY, Professor, University Paris 7 - Denis Diderot
ClinicalTrials.gov Identifier: NCT03002584     History of Changes
Other Study ID Numbers: IGQ
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Olivier CHASSANY, University Paris 7 - Denis Diderot:
IBS, population
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases