Gastrointestinal Symptoms in Healthy Subjects and Patients With Irritable Bowel Syndrome

• ClinicalTrials.gov Identifier: NCT01457378
• Recruitment Status: Completed
• First Posted: October 24, 2011
• Last Update Posted: September 20, 2016
• Sponsor: Danone Research
• Information provided by (Responsible Party): Danone Research

Study Description

Brief Summary:

The aim of this study performed in Irritable Bowel Syndrome (IBS) subjects and healthy patients is to demonstrate the ability of composite score of frequency of gastrointestinal symptoms to discriminate healthy subjects and IBS patients. The properties of this questionnaire of composite score of gastrointestinal symptoms frequency will be compared to other validated questionnaires (severity of IBS symptoms and HRQoL).

Condition or disease
Irritable Bowel Syndrome

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Assessment of Gastrointestinal Symptoms and Health-related Quality of Life in Healthy People and Patients With Irritable Bowel Syndrome
• Study Start Date: September 2011
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: November 2011

Groups and Cohorts

Group/Cohort
Healthy volunteers; 100 healthy volunteers
IBS Subjects; 100 IBS Subjects

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Adult healthy subjects and adult IBS patients (Rome III criteria, all subtype)

Criteria

Inclusion Criteria:

• for Healthy subjects :
• Healthy women and men free-living subject aged from 18 to 65 years.
• Subject with a body mass index between 18 and 30, bounds included.
• Subject having given written consent to take part in the study.
• Chronic medical treatment-free excluding contraceptive and stable Hormonal Replacement Therapy
• for IBS Patients :
• IBS women and men free-living subject aged from 18 to 65 years
• Subject with a diagnosis of IBS according to Rome III criteria: recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following: improvement with defecation; onset associated with a change in frequency of stool; onset associated with a change in form (appearance) of stool.
• Subject with a diagnosis of IBS according to Rome III criteria with symptom onset at least 6 months prior to diagnosis.
• Subject having an IBS-SSS score higher or equal to 75 corresponding to an active phase of IBS symptoms.
• Subject having given written consent to take part in the study.

Exclusion Criteria:

• for Healthy subjects :
• Subject who, in the past, has consulted a general practitioner or a gastroenterologist for (IBS) or any other functional bowel disease including constipation and diarrhoea.
• Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
• Subject treated with any chronic medical treatment that, in the investigator's opinion could interfere with the GI tract.
• Subject who underwent general anaesthesia in the preceding 4 weeks.
• Pregnant subject or breast-feeding subject at the time of the study.
• Subject with known immunosuppression
• Subject with any known food allergy
• Subject involved in any other clinical study within the preceding month or in exclusion period after another clinical study.
• Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
• Subject not able to read, to understand and/or to answer to the questionnaires.
• for IBS Patients :
• If a subject fulfils with one of the following criteria, he/she must be excluded from the study:
• Subject with a diagnosis of IBS with clinical signs of alarm (rectorragy, fever, associated inflammatory articular signs, recent weight loss).
• Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease.
• Subject who underwent general anaesthesia in the preceding 4 weeks.
• Pregnant subject or breast-feeding subject at the time of the study.
• Subject involved in any other clinical study within the preceding month or in exclusion period after another clinical study.
• Taking antidepressant or analgesic drugs.
• Subject not able to read, to understand and/or to answer to the questionnaires.

Contacts and Locations

Locations

France

Eurofins Optimed

Gieres, France, 38610

Biofortis

Nantes, France, 44200

Sponsors and Collaborators

Danone Research

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Azpiroz F, Guyonnet D, Donazzolo Y, Gendre D, Tanguy J, Guarner F. Digestive Symptoms in Healthy People and Subjects With Irritable Bowel Syndrome: Validation of Symptom Frequency Questionnaire. J Clin Gastroenterol. 2015 Aug;49(7):e64-70. doi: 10.1097/MCG.0000000000000178.

• Responsible Party: Danone Research
• ClinicalTrials.gov Identifier: NCT01457378
• Other Study ID Numbers: NU357
• First Posted: October 24, 2011
• Last Update Posted: September 20, 2016
• Last Verified: September 2016

Keywords provided by Danone Research:

Gastrointestinal symptoms; healthy subjects; IBS; HRQoL; questionnaires

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases