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Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00987311
Enrollment
33
Registered
2009-09-30
Start date
2009-09-30
Completion date
2011-12-31
Last updated
2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Probiotics, intestinal immune system, human, healthy subjects, dairy drink, Healthy adults

Brief summary

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.

Interventions

DIETARY_SUPPLEMENT1- Dairy drink containing probiotics A

1- Dairy drink containing probiotics A

DIETARY_SUPPLEMENT2- Dairy drink containing probiotics B

2- Dairy drink containing probiotics B

DIETARY_SUPPLEMENT3- Dairy drink without probiotics (control)

3- Dairy drink without probiotics (control)

Sponsors

Danone Global Research & Innovation Center
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026