Skip to main content
OpenTrials
Completed

NCT Number: NCT01388010

Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Adult Women

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RPS Research France

Caen, 14052, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

1-Fermented Probiotic Dairy Product (test)

Other

2-Milk-based non-fermented dairy product(control)

Other

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

"Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 6, 2011
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.