NCT01388010CompletedNot Applicable
"Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"
Danone Global Research & Innovation Center1 site in 1 country336 target enrollmentStarted: September 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 336
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female free-living subject aged from 18 to 60 years.
- •Subject with a body mass index between 18 and
- •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)
Arms & Interventions
1 = Test product
Experimental
Arm 1 - Intervention 1 (probiotics)
Intervention: 1-Fermented Probiotic Dairy Product (test) (Other)
2 = Control product
Other
Arm 2 - Intervention 2 (control)
Intervention: 2-Milk-based non-fermented dairy product(control) (Other)
Investigators
Study Sites (1)
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