Common Infectious DiseasesNCT01200173
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
A study testing 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) in people with Common Infectious Diseases, run by Danone Global Research & Innovation Center at 1 site in Russia.
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 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Infectious Diseases
- 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
- 600 participants
- Where
- 1 siteRussia
- Study dates
- Nov 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject whose parents/legal guardians had given written informed consent,
- Male or female, aged 3 to 6 years (upper bound excluded),
- Attending day-care centres or preschools 5 days a week in the Moscow area,
- Subject found medically healthy (in particular, free of respiratory and GI tract symptoms),
- Subject who appreciated dairy products and multi-fruit flavour.
Who cannot join
- Subject whose parents were not reading and writing Russian, or not understanding informed consent or study protocol.
- Subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), 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 could interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive…).
- Subject having experienced any infectious disease during the last 7 days.
- Subject with current diarrhoea or constipation Subject who was frequently using laxatives or who had 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.
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- Subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation…) or with eating disorders (anorexia, bulimia…).
- Subject currently receiving, or who had 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 antiinflammatory substances, immunosuppressant treatment…
- Subject already enrolled in another clinical study, or currently under an exemption period from a previous 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.
Russia1 site
Federal State Institution "Federal research center of pediatric hematology, oncology and imunology"
Moscow, 117997
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) in children aged 3-6 years, attending day care centers.Volunteers received either 200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a 1-month follow-up.
- Conditions
- Common Infectious Diseases
- 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 - children
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 posted13 Sep 2010 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common 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
- 600 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
- NCT01200173
- Sponsor's protocol ID
- NU206
- Status last verified
- Nov 2016
- First submitted
- 10 Sep 2010
- Last updated
- 25 Nov 2016
- Results posted
- No
Publications
Prodeus A, Niborski V, Schrezenmeir J, Gorelov A, Shcherbina A, Rumyantsev A. Fermented Milk Consumption and Common Infections in Children Attending Day-Care Centers: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):534-543. doi: 10.1097/MPG.0000000000001248.
PubMed 27168455
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 Children Aged 3-6 Years, Attending Day Care Centers
- ClinicalTrials.gov ID
- NCT01200173
- Acronym / sponsor ID
- NU206
- Conditions
- Common Infectious Diseases
- Keywords
- Probiotic - Lactobacillus casei DN-114 001 - dairy, product - infections - children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Sep 2010 (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) in children aged 3-6 years, attending day care centers.Volunteers received either 200g/day of tested product (N=300) or control product (N=299) 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 |
|---|---|---|
| 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
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject whose parents/legal guardians had given written informed consent,
- Male or female, aged 3 to 6 years (upper bound excluded),
- Attending day-care centres or preschools 5 days a week in the Moscow area,
- Subject found medically healthy (in particular, free of respiratory and GI tract symptoms),
- Subject who appreciated dairy products and multi-fruit flavour.
Key exclusion criteria (10 listed)
- Subject whose parents were not reading and writing Russian, or not understanding informed consent or study protocol.
- Subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), 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 could interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive…).
- Subject having experienced any infectious disease during the last 7 days.
- Subject with current diarrhoea or constipation Subject who was frequently using laxatives or who had been using laxatives during the week prior his participation to the study.
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 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 25 Nov 2016.
- Derived from this study: PubMed 27168455Prodeus A, Niborski V, Schrezenmeir J, Gorelov A, Shcherbina A, Rumyantsev A. Fermented Milk Consumption and Common Infections in Children Attending Day-Care Centers: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):534-543. doi: 10.1097/MPG.0000000000001248.
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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 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) in people with Common Infectious Diseases, run by Danone Global Research & Innovation Center at 1 site in Russia.
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 10 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: finished, 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 Russia. 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?
On the ClinicalTrials.gov record for NCT01200173, which also lists 1 linked publication.
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.