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

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01315418
• Other study ID #: NU201
• 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

Related Conditions & MeSH terms

• Bronchitis
• Communicable Diseases
• Flu
• Flu-like Syndromes
• Gastroenteritis
• Infection
• Lower Respiratory Tract Infections
• Lung Diseases
• Nasopharyngitis
• Otitis
• Pharyngitis
• Pneumopathy
• Respiratory Tract Infections
• Rhinopharyngitis
• Sinusitis
• Sore Throat
• Upper Respiratory Tract Infections

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,