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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01315418
Other study ID # NU201
Secondary ID
Status Terminated
Phase N/A
First received March 14, 2011
Last updated November 23, 2016
Start date December 2006
Est. completion date July 2007

Study information

Verified date November 2016
Source Danone Research
Contact n/a
Is FDA regulated No
Health authority France: AFSSAPS
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Intervention

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

2-Non fermented dairy product (control)


Locations

Country Name City State
France Médecin-chef du Groupement Formation Instruction Villeneuve Saint-Georges

Sponsors (1)

Lead Sponsor Collaborator
Danone Research

Country where clinical trial is conducted

France, 

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