Gastrointestinal Symptoms in Healthy Subjects and Patients With Irritable Bowel Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2016
• Main ID: NCT01457378
• Date of registration: 19/10/2011
• Prospective Registration: No
• Primary sponsor: Danone Research
• Public title: Gastrointestinal Symptoms in Healthy Subjects and Patients With Irritable Bowel Syndrome
• Scientific title: Assessment of Gastrointestinal Symptoms and Health-related Quality of Life in Healthy People and Patients With Irritable Bowel Syndrome
• Date of first enrolment: September 2011
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01457378
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Secondary ID(s)

NU357

Source(s) of Monetary Support

Please refer to primary and secondary sponsors