Status:
COMPLETED
Gastrointestinal Symptoms in Healthy Subjects and Patients With Irritable Bowel Syndrome
Lead Sponsor:
Danone Global Research & Innovation Center
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
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 discrimina...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01457378
Start Date
September 1 2011
End Date
November 1 2011
Last Update
September 20 2016
Active Locations (2)
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1
Eurofins Optimed
Gières, France, 38610
2
Biofortis
Nantes, France, 44200