An observational study in IBS - Irritable Bowel Syndrome and General Population, sponsored by University Paris 7 - Denis Diderot. Completed at 5 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by University Paris 7 - Denis Diderot · Observational
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):
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's enrollment of 300 is above the median of 160 across 191 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University Paris 7 - Denis Diderot is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Psychometric validation of the IGQ
Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire
Time frame: cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants
Electronic version of the IGQ
Comparison of scores between paper and electronic version of IGQ
Time frame: During test-retest within an interval of 7 days
Plan to share: No
Ran from Feb 2017 to primary completion in Apr 2018, 14 months.
Of 51 non-industry observational studies under Irritable Bowel Syndrome, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 193. This study's 14 months is below that.
Counting every sponsor, half of 65 studies reached it within 40 months; a quarter within 21 and three quarters within 109.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University Paris 7 - Denis Diderot