Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Primary Purpose
Upper Respiratory Tract Infections, Rhinopharyngitis, Sore Throat
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
2-Non fermented dairy product (control)
Sponsored by
About this trial
This is an interventional basic science trial for Upper Respiratory Tract Infections focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Médecin-chef du Groupement Formation Instruction
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
1 = Tested product
2 = Control product
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01315418
Brief Title
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Official Title
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, Rhinopharyngitis, Sore Throat, Sinusitis, Otitis, Lower Respiratory Tract Infections, Bronchitis, Pneumopathy, Flu, Flu-like Syndromes, Gastroenteritis
Keywords
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 = Tested product
Arm Type
Active Comparator
Arm Title
2 = Control product
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Intervention Type
Other
Intervention Name(s)
2-Non fermented dairy product (control)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Médecin-chef du Groupement Formation Instruction
City
Villeneuve Saint-Georges
ZIP/Postal Code
94190
Country
France
12. IPD Sharing Statement
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Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
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