Gastrointestinal Symptoms in Healthy Subjects and Patients With Irritable Bowel Syndrome

Assessment of Gastrointestinal Symptoms and Health-related Quality of Life in Healthy People and Patients With Irritable Bowel Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Gieres, France, 38610
    • Eurofins Optimed
  • Nantes, France, 44200
    • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Danone Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (ESTIMATE): October 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: IBS; healthy subjects; Gastrointestinal symptoms; HRQoL; questionnaires
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: NU357