Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
This study has been terminated.
Sponsor:
Danone Research
Collaborator:
Dr Cédric ERNOUF
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01315418
First received: March 14, 2011
Last updated: May 3, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Upper Respiratory Tract Infections Rhinopharyngitis Sore Throat Sinusitis Otitis Lower Respiratory Tract Infections Bronchitis Pneumopathy Flu Flu-like Syndromes Gastroenteritis |
Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) Other: 2-Non fermented dairy product (control) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Basic Science |
| Official Title: | Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation |
Resource links provided by NLM:
Further study details as provided by Danone Research:
| Study Start Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 = Tested product | Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) |
| Sham Comparator: 2 = Control product | Other: 2-Non fermented dairy product (control) |
Eligibility| Ages Eligible for Study: | 18 Years to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01315418 History of Changes |
| Other Study ID Numbers: | NU201 |
| Study First Received: | March 14, 2011 |
| Last Updated: | May 3, 2011 |
| Health Authority: | France: AFSSAPS |
Keywords provided by Danone Research:
|
Probiotic - Lactobacillus casei DN-114 001 - dairy product - infections - firemen Common infectious diseases, occuring in healthy subjects, including upper respiratory tract infections (defined as |
rhinopharyngitis, sore throat, sinusitis and otitis) lower respiratory tract infections (defined as bronchitis pneumopathy and flu and flu-like syndromes) gastrointestinal tract infection defined as gastroenteritis |
Additional relevant MeSH terms:
|
Bronchitis Gastroenteritis Lung Diseases Nasopharyngitis Otitis Pharyngitis Respiratory Tract Infections Sinusitis Common Cold Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Gastrointestinal Diseases |
Digestive System Diseases Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Ear Diseases Infection Paranasal Sinus Diseases Nose Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013