Sinusitis Clinical Trial
Official title:
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Verified date | November 2016 |
Source | Danone Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: AFSSAPS |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 239 |
Est. completion date | July 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 29 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | Médecin-chef du Groupement Formation Instruction | Villeneuve Saint-Georges |
Lead Sponsor | Collaborator |
---|---|
Danone Research |
France,
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