Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women
Not Applicable
Completed
- Conditions
- Healthy Adult Women
- Registration Number
- NCT01388010
- Lead Sponsor
- Danone Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 336
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which probiotics in NCT01388010 improve gastrointestinal well-being in women with minor digestive symptoms?
How does the fermented dairy product in NCT01388010 compare to standard-of-care treatments for minor digestive symptoms in adult women?
What biomarkers could predict response to probiotic interventions in NCT01388010 for gastrointestinal health?
What are the potential adverse events associated with probiotic consumption in NCT01388010 and how are they managed?
Are there related compounds or combination therapies with probiotics that enhance gastrointestinal well-being in women?
Trial Locations
- Locations (1)
RPS Research France
🇫🇷Caen, France
RPS Research France🇫🇷Caen, France