Upper Respiratory Tract InfectionsNCT01315418
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
A study testing 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) in people with Upper Respiratory Tract Infections and Rhinopharyngitis, run by Danone Global Research & Innovation Center at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, Rhinopharyngitis, Sore Throat
- What is being tested?
- 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Médecin-chef du Groupement Formation Instruction
Villeneuve-Saint-Georges, 94190
About this study
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.
- Conditions
- Upper Respiratory Tract Infections, Rhinopharyngitis, Sore Throat, Sinusitis, Otitis, Lower Respiratory Tract Infections
- Being tested
- 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®), 2-Non fermented dairy product (control)
- Keywords
- 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
- Medical subject headings
- Respiratory Tract Infections, Nasopharyngitis, Pharyngitis, Sinusitis, Otitis, Bronchitis, Lung Diseases, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)Other
2-Non fermented dairy product (control)Other
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Active comparator | Not described Receives: Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) |
| 2 = Control product | Sham comparator | Not described Receives: Other: 2-Non fermented dairy product (control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startDec 2006
- Primary completionMay 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315418
- Sponsor's protocol ID
- NU201
- Status last verified
- Nov 2016
- First submitted
- 14 Mar 2011
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
- ClinicalTrials.gov ID
- NCT01315418
- Acronym / sponsor ID
- NU201
- Conditions
- Upper Respiratory Tract Infections, Rhinopharyngitis, Sore Throat, Sinusitis, Otitis, Lower Respiratory Tract Infections
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
Related trials for Upper Respiratory Tract Infections
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Recruiting
Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds
Acute Otitis Media (AOM), Upper Respiratory Infection
Not yet recruiting
Probiotics for Sustained Health
Upper Respiratory Tract Infection (URTI)
Not yet recruitingObservational study
PRAE and Asymptomatic and Symptomatic URI Patients
Upper Respiratory Infection, Pediatric Surgical Patients
Not yet recruiting
Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea
Antibiotic Associated Diarrhea, Upper Respiratory Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) in people with Upper Respiratory Tract Infections and Rhinopharyngitis, run by Danone Global Research & Innovation Center at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016; AzTrials last refreshed its copy on 26 Oct 2026.