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OpenTrials
Completed

NCT Number: NCT00987311

Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

The purpose of this study is to investigate whether two different fermented dairy drinks consumed daily could have an effect on the intestinal immune response in healthy subjects.

Completed

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male/female subjects aged from 18 to 45 years (bounds included).
  • Subjects with none of the symptoms of gastrointestinal infectious diseases
  • Subjects with a body mass index (BMI) between 19 and 30 kg/m² (bounds included).
  • Subjects who accept to be submitted to an alimentary restriction of product with OTC and foods containing probiotics and/or prebiotics
  • Subjects who regularly consume and appreciate dairy products
  • Subjects who have not consumed any products or OTCs containing probiotics within the last three months.

Exclusion criteria

  • Subjects in a situation that, in the investigator opinion, could interfere with optimal participation in the present study (e.g. non dairy-products consumer) or could constitute a special risk for the subject.
  • Subjects with allergies or hypersensitivity to any component of the study product (e.g: allergy or hypersensitivity to milk proteins, or lactose intolerance)
  • Subjects with any food allergy
  • Subjects with auto-immune or with chronic disease or with a history of chronic metabolic or gastrointestinal.
  • Subjects who have had any surgery or intervention requiring general anaesthesia in the last 4 weeks..
  • Subjects with special diet requirements
  • For female subjects: pregnancy, breast feeding or no method of contraceptive used
  • Subjects participating in any other interventional study concomitantly or within 4 weeks of the study entry date.

Treatment and study plan

1- Dairy drink containing probiotics A

Dietary Supplement

1- Dairy drink containing probiotics A

2- Dairy drink containing probiotics B

Dietary Supplement

2- Dairy drink containing probiotics B

3- Dairy drink without probiotics (control)

Dietary Supplement

3- Dairy drink without probiotics (control)

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

Pilot Study on the Effects of Probiotic Fermented Dairy Drinks on the Intestinal Immune Response in Healthy Adults

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Sep 30, 2009
Registry last updated
Jan 20, 2017

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.

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