IBS - Irritable Bowel SyndromePRoVINGNCT03002584
International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
An observational study of IBS - Irritable Bowel Syndrome and General Population, run by University Paris 7 - Denis Diderot at 5 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, General Population
- What is being tested?
- completion of self-reported questionnaires
- How many people
- 300 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Feb 2017to 10 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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…)
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain3 sites
Centro de salud Chafarinas
Barcelona, 08033
Horta, Hospital Universitari Vall d'Hebron
Barcelona, 08035
Centre Mèdic Sant Andreu
Barcelona, 08740
About this study
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)
Read the 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)
- Conditions
- IBS - Irritable Bowel Syndrome, General Population
- Being tested
- completion of self-reported questionnaires
- Keywords
- IBS, population
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of self-reported questionnairesOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: completion of self-reported questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validation of the IGQ
Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire
Measured: 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
Comparison of scores between paper and electronic version of IGQ
Measured: During test-retest within an interval of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start10 Feb 2017
- Primary completion30 Apr 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Collaborators
- EA 7334, Patient-Centered Outcomes Research, University of Manchester, Hospital Vall d'Hebron, Hôpital Louis Mourier
- Responsible party
- Principal investigator, Olivier CHASSANY, University Paris 7 - Denis Diderot
- Investigators
- Olivier Chassany, MD, PhD, Study chair, EA 7334, University Paris-Diderot, ParisPeter Whorwell, MD, PhD, Principal investigator, university of Manchester, ManchesterFernando Azpiroz, MD, PhD, Principal investigator, Hospital Vall d'Hebron, BarcelonaBenoit Coffin, MD, PhD, Principal investigator, Hopital Louis Mourier, ColombesMartin Duracinsky, MD, PhD, Study director, EA 7334, University Paris-Diderot, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002584
- Sponsor's protocol ID
- IGQ
- Acronym
- PRoVING
- Status last verified
- Feb 2019
- First submitted
- 20 Dec 2016
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25846412
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)
- ClinicalTrials.gov ID
- NCT03002584
- Acronym / sponsor ID
- PRoVING / IGQ
- Conditions
- IBS - Irritable Bowel Syndrome, General Population
- Keywords
- IBS, population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Collaborators
- EA 7334, Patient-Centered Outcomes Research, University of Manchester, Hospital Vall d'Hebron, Hôpital Louis Mourier
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBS & general population | – | Other: completion of self-reported questionnairesThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)
Key inclusion criteria (11 listed)
- 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
- IBS diagnosis using Rome III diagnostic criteria for Functional Gastrointestinal Disorders (21)
Key exclusion criteria (10 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| completion of self-reported questionnairesSingle 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 | IBS & general population |
Primary outcome
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
1 secondary outcome
Electronic version of the IGQ
Time frame: During test-retest within an interval of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Background: PubMed 25846412Chassany 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Chassany, MD, PhD study chair
EA 7334, University Paris-Diderot, Paris
Peter Whorwell, MD, PhD principal investigator
university of Manchester, Manchester
Fernando Azpiroz, MD, PhD principal investigator
Hospital Vall d'Hebron, Barcelona
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBS - Irritable Bowel Syndrome and General Population, run by University Paris 7 - Denis Diderot at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.