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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Paris 7 - Denis Diderot

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Manchester
Hospital Vall d'Hebron
Hôpital Louis Mourier
EA 7334, Patient-Centered Outcomes Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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