Gastrointestinal Symptoms in Healthy Subjects and Patients With Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01457378
First received: October 19, 2011
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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
Irritable Bowel Syndrome

Study Type: Observational
Study Design: 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

Further study details as provided by Danone Research:

Estimated Enrollment: 200
Study Start Date: September 2011
Study Completion Date: June 2012
Groups/Cohorts
Healthy volunteers
100 healthy volunteers
IBS Subjects
100 IBS Subjects

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457378

Locations
France
Eurofins Optimed
Gieres, France, 38610
Biofortis
Nantes, France, 44200
Sponsors and Collaborators
Danone Research
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01457378     History of Changes
Other Study ID Numbers: NU357
Study First Received: October 19, 2011
Last Updated: June 25, 2012
Health Authority: France : AFSSAPS

Keywords provided by Danone Research:
Gastrointestinal symptoms
healthy subjects
IBS
HRQoL
questionnaires

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014