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

Last updated: November 23, 2016
Sponsor: Danone Research
Overall Status: Terminated

Phase

N/A

Condition

Gastroenteritis

Acute Rhinitis

Influenza

Treatment

N/A

Clinical Study ID

NCT01315418
NU201
  • Ages 18-29
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 andmulti-fruit flavour.

Exclusion

Exclusion Criteria:

  • Subject who is not reading and writing French, or not understanding informed consentor 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 actualhealth 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 theweek prior his participation to the study

  • subject who was under artificial nutrition, had gastro-intestinal surgery or anyintervention requiring general anaesthesia the last 2 months prior to hisparticipation 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, systemictreatment or topical treatment likely to interfere with evaluation of the studyparameters: antibiotics, antiseptics,antifungal, corticoids, vaccines, anti-histaminicmolecules, non-corticoid anti-inflammatory substances, immunosuppressant treatment…

  • subject already enrolled in another clinical study, or currently under an exemptionperiod from a previous study

  • female subject who is currently pregnant or breast-feeding, or willing to becomepregnant during the 2 coming months after enrolment in the study

  • subject in a situation which in the investigator's opinion could interfere withoptimal participation in the present study or could constitute a special risk for thesubject

Study Design

Total Participants: 239
Study Start date:
December 01, 2006
Estimated Completion Date:
July 31, 2007

Connect with a study center

  • Médecin-chef du Groupement Formation Instruction

    Villeneuve Saint-Georges, 94190
    France

    Site Not Available

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