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Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

NCT ID: NCT01315418

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-07-31

Brief Summary

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This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.

Detailed Description

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Conditions

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Upper Respiratory Tract Infections Rhinopharyngitis Sore Throat Sinusitis Otitis Lower Respiratory Tract Infections Bronchitis Pneumopathy Flu Flu-like Syndromes Gastroenteritis

Keywords

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Probiotic - Lactobacillus casei DN-114 001 - dairy product - infections - firemen Common infectious diseases, occuring in healthy subjects, including upper respiratory tract infections (defined as rhinopharyngitis, sore throat, sinusitis and otitis) lower respiratory tract infections (defined as bronchitis pneumopathy and flu and flu-like syndromes) gastrointestinal tract infection defined as gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Tested product

Group Type ACTIVE_COMPARATOR

1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)

Intervention Type OTHER

2 = Control product

Group Type SHAM_COMPARATOR

2-Non fermented dairy product (control)

Intervention Type OTHER

Interventions

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1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)

Intervention Type OTHER

2-Non fermented dairy product (control)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* male and female aged 18-29 years
* attending 7 weeks of firemen training school
* a 19 to 29 kg/m2 body mass index
* found medically healthy (in particular, free of respiratory and GI tract symptoms)
* agreeing to a written informed consent, and who appreciates dairy products and multi-fruit flavour.

Exclusion Criteria

* Subject who is not reading and writing French, or not understanding informed consent or study protocol
* subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose), or with any known food or respiratory allergy;
* subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes…) or any past or actual health condition that may interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease…)
* subject having experienced any infectious disease during the last 7 days
* subject with current diarrhoea or constipation
* subject who is frequently using laxatives or who has been using laxatives during the week prior his participation to the study
* subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study
* subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation…) or with eating disorders (anorexia, bulimia, alcoholism…)
* subject currently receiving, or who has received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics,antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid anti-inflammatory substances, immunosuppressant treatment…
* subject already enrolled in another clinical study, or currently under an exemption period from a previous study
* female subject who is currently pregnant or breast-feeding, or willing to become pregnant during the 2 coming months after enrolment in the study
* subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Médecin-chef du Groupement Formation Instruction

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

Other Identifiers

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NU201

Identifier Type: -

Identifier Source: org_study_id