Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women
This study has been completed.
Sponsor:
Danone Research
Collaborator:
RPS Research France
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01388010
First received: July 3, 2011
Last updated: July 5, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.
| Condition | Intervention |
|---|---|
|
Healthy Adult Women |
Other: 1-Fermented Probiotic Dairy Product (test) Other: 2-Milk-based non-fermented dairy product(control) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms" |
Further study details as provided by Danone Research:
| Estimated Enrollment: | 380 |
| Study Start Date: | September 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 = Test product
Arm 1 - Intervention 1 (probiotics)
|
Other: 1-Fermented Probiotic Dairy Product (test) |
|
2 = Control product
Arm 2 - Intervention 2 (control)
|
Other: 2-Milk-based non-fermented dairy product(control) |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Female free-living subject aged from 18 to 60 years.
- Subject with a body mass index between 18 and 30.
- Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
- Subject with normal stool frequency
Exclusion Criteria:
- Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, 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 under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
- Subject having taken antibiotics in the last 4 weeks
- Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
- Subject with known lactose intolerance or immunodeficiency
- Subject with known allergy to product component (milk protein for example)
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01388010 History of Changes |
| Other Study ID Numbers: | NU325 |
| Study First Received: | July 3, 2011 |
| Last Updated: | July 5, 2011 |
| Health Authority: | France: AFSSAPS |
Keywords provided by Danone Research:
|
probiotics gastrointestinal well being digestive symptoms healthy population |
ClinicalTrials.gov processed this record on May 23, 2013