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

NCT03002584 | Completed

• 1 other identifier: IGQ
• Study Type: observational
• Target: 300
• Locations: 3 countries
• Sites: 5

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)

Conditions

IBS - Irritable Bowel Syndrome; General Population

Keywords

IBS, population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Electronic version of the IGQ

  During test-retest within an interval of 7 days

Study Arms (1)

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

Interventions

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

IBS & general population

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Paris 7 - Denis Diderot: lead
• EA 7334, Patient-Centered Outcomes Research: collaborator
• University of Manchester: collaborator
• Hospital Vall d'Hebron: collaborator
• Hôpital Louis Mourier: collaborator

Study Sites (5)

Hopital Louis Mourier

Colombes, 92700, France

Location

Centro de salud Chafarinas

Barcelona, 08033, Spain

Location

Horta, Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Centre Mèdic Sant Andreu

Barcelona, 08740, Spain

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Related 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.

  PMID: 25846412 BACKGROUND

Related Links

• Results of the qualitative analysis

MeSH Terms

Conditions

Irritable Bowel Syndrome; Ichthyosis Bullosa of Siemens

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olivier Chassany, MD, PhD

  EA 7334, University Paris-Diderot, Paris

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Martin Duracinsky, MD, PhD

  EA 7334, University Paris-Diderot, Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 26, 2016
• Study Start: February 10, 2017
• Primary Completion: April 30, 2018
• Study Completion: July 10, 2018
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); FR (1); ES (3)