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| Name | Class |
|---|---|
| EA 7334, Patient-Centered Outcomes Research | UNKNOWN |
| University of Manchester | OTHER |
| Hospital Vall d'Hebron | OTHER |
| Hôpital Louis Mourier |
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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)
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Electronic version of the IGQ | Comparison of scores between paper and electronic version of IGQ | During test-retest within an interval of 7 days |
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Inclusion Criteria:
All (subjects with IBS diagnosis and general population):
Subjects with IBS diagnosis:
General population:
Exclusion criteria
All (subjects with IBS diagnosis and general population):
General population:
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IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Louis Mourier | Colombes | 92700 | France | |||
| Centro de salud Chafarinas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25846412 | Background | 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. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D053560 | Ichthyosis Bullosa of Siemens |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| OTHER |
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|
| Barcelona |
| 08033 |
| Spain |
| Horta, Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Centre Mèdic Sant Andreu | Barcelona | 08740 | Spain |
| Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| D004066 | Digestive System Diseases |
| D007057 | Ichthyosis |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |