Infectious DiseasesNCT01033799
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
A study testing Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) in people with Infectious Diseases and Healthy Subjects, run by Danone Global Research & Innovation Center at 1 site in Germany.
Trial summary
This single-center, 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 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases, Healthy Subjects, Respiratory Tract Infections
- What is being tested?
- 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
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria: male and female aged 18-65 years; working in 2- or 3-shift work patterns (including night work); same job position for at least 4.5 months; a 19 to 30 kg/m2 body mass index; no symptoms of CIDs during the 2 weeks before product consumption; agreeing to a written informed consent.
Exclusion criteria: part time work (<90%); allergy/hypersensitivity to components of the study product; severe respiratory allergy; a situation which, in the investigator's opinion, could interfere with optimal participation or constitute a special risk for the volunteer; a history of chronic metabolic/gastro-intestinal disease (except appendectomy); surgery/intervention requiring general anesthesia in the last 4 weeks; administration of systemic/topical treatments likely to interfere with the evaluation parameters in the last 4 weeks; chronic disease requiring antibiotics/antiseptics/anti-inflammatory medications; special medicated diet; chronic/iatrogenic immunodeficiency; cardiac/renal/respiratory insufficiency; severe evolutive/chronic pathology; pregnancy, breast feeding or lacking effective contraception in females; susceptibility not to comply with dietary recommendation during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
This single-center, 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 immune functions in healthy shift workers. Volunteers received either 200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a 1-month follow-up.
- Conditions
- Infectious Diseases, Healthy Subjects, Respiratory Tract Infections, Sore Throat, Sinusitis, Otitis
- Being tested
- Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®), Non fermented dairy product (control)
- Keywords
- Probiotic - Lactobacillus casei DN114-001, dairy product - infections - shiftworkers, 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), and, gastrointestinal tract infection defined as gastroenteritis.
- Medical subject headings
- Communicable Diseases, Respiratory Tract Infections, Pharyngitis, Sinusitis, Otitis, Bronchitis, Pneumonia, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)Other
Non fermented dairy product (control)Other
| Study group | Role | What they receive |
|---|---|---|
| Control Product | Sham comparator | Not described Receives: Other: Non fermented dairy product (control) |
| Tested Product | Active comparator | Not described Receives: Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startOct 2006
- Primary completionApr 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies 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
- 1,000 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
- NCT01033799
- Sponsor's protocol ID
- NU207
- Status last verified
- Jan 2017
- First submitted
- 16 Dec 2009
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. 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 Shift-workers
- ClinicalTrials.gov ID
- NCT01033799
- Acronym / sponsor ID
- NU207
- Conditions
- Infectious Diseases, Healthy Subjects, Respiratory Tract Infections, Sore Throat, Sinusitis, Otitis
- Keywords
- Probiotic - Lactobacillus casei DN114-001, dairy product - infections - shiftworkers, 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), and, gastrointestinal tract infection defined as gastroenteritis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 17 Dec 2009 (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 single-center, 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 immune functions in healthy shift workers. Volunteers received either 200g/day of tested product (N=500) or control product (N=500) for 3-months, followed by a 1-month follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Product | Sham comparator | Other: Non fermented dairy product (control) |
| Tested Product | Active comparator | Other: Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) | Other | Tested Product |
| Non fermented dairy product (control) | Other | Control Product |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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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 Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) in people with Infectious Diseases and Healthy Subjects, run by Danone Global Research & Innovation Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 20 Jan 2017. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 20 Jan 2017.