NCT01315418

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

March 14, 2011

Last Update Submit

November 23, 2016

Conditions

Upper Respiratory Tract InfectionsRhinopharyngitisSore ThroatSinusitisOtitisLower Respiratory Tract InfectionsBronchitisPneumopathyFluFlu-like SyndromesGastroenteritis

Keywords

Probiotic - Lactobacillus casei DN-114 001 - dairy product -infections - firemenCommon infectious diseases, occuring in healthy subjects,including upper respiratory tract infections (defined asrhinopharyngitis, sore throat, sinusitis and otitis)lower respiratory tract infections (defined as bronchitispneumopathy and flu and flu-like syndromes)gastrointestinal tract infection defined as gastroenteritis

Study Arms (2)

1 = Tested product

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

2 = Control product

SHAM COMPARATOR
Other: 2-Non fermented dairy product (control)

Interventions

1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)OTHER
1 = Tested product
2-Non fermented dairy product (control)OTHER
2 = Control product

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Médecin-chef du Groupement Formation Instruction

Villeneuve-Saint-Georges, 94190, France

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsNasopharyngitisPharyngitisSinusitisOtitisBronchitisLung DiseasesInfluenza, HumanGastroenteritis

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesParanasal Sinus DiseasesNose DiseasesEar DiseasesBronchial DiseasesLung Diseases, ObstructiveOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

December 1, 2006

Primary Completion

May 1, 2007

Study Completion

July 1, 2007

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

FR(1)