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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 20, 2016
First Posted Date December 26, 2016
Last Update Posted Date February 18, 2019
Actual Study Start Date February 10, 2017
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03002584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 20, 2016)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
Official Title International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
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)

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)
Condition
  • IBS - Irritable Bowel Syndrome
  • General Population
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

Study Groups/Cohorts 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.

Intervention: Other: completion of self-reported questionnaires
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 20, 2016)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date July 10, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03002584
Other Study ID Numbers IGQ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Olivier CHASSANY, University Paris 7 - Denis Diderot
Study Sponsor University Paris 7 - Denis Diderot
Collaborators
  • EA 7334, Patient-Centered Outcomes Research
  • University of Manchester
  • Hospital Vall d'Hebron
  • Hôpital Louis Mourier
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'Hebron, Barcelona
Principal Investigator: Benoit Coffin, MD, PhD Hopital Louis Mourier, Colombes
Study Director: Martin Duracinsky, MD, PhD EA 7334, University Paris-Diderot, Paris
PRS Account University Paris 7 - Denis Diderot
Verification Date February 2019