Respiratory Tract InfectionsPhase 3NCT01014676
Probiotics and Infections in Children Attending Day Care Centres
A Phase 3 study testing Probiotic in people with Respiratory Tract Infections and Gastrointestinal Diseases, run by Valio Ltd at 1 site in Finland.
Trial summary
The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Respiratory Tract Infections, Gastrointestinal Diseases
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 2 to 6 years
- All sexes
- Child
Who may be able to join
- Age 2 to 6 years in the beginning of the intervention
- Attendance at a day care centre participating in the study (5 days a week)
Who cannot join
- Milk allergy or lactose intolerance
- Congenital heart diseases that requires regular medication
- Malign diseases
- Cytostatic treatment
- Use of biological rheumatic medication
- Continuous microbial medication
Show all 9Show fewer
- Regular use of oral corticosteroids (inhalable accepted)
- Diabetes
- Simultaneous participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.
- Being tested
- Probiotic, Placebo
- Keywords
- Costs and Cost Analysis
- Medical subject headings
- Respiratory Tract Infections, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Probiotic milk | Active comparator | Not described Receives: Dietary Supplement: Probiotic |
| Standard milk | Placebo comparator | Not described Receives: Other: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
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 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 3
Sponsor and investigators
- Lead sponsor
- Valio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki
- Investigators
- Anne Pitkäranta, Professor, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014676
- Sponsor's protocol ID
- Valio-69
- Status last verified
- Jul 2011
- First submitted
- 16 Nov 2009
- Last updated
- 7 Jul 2011
- Results posted
- No
Publications
Korpela K, Salonen A, Virta LJ, Kumpu M, Kekkonen RA, de Vos WM. Lactobacillus rhamnosus GG Intake Modifies Preschool Children's Intestinal Microbiota, Alleviates Penicillin-Associated Changes, and Reduces Antibiotic Use. PLoS One. 2016 Apr 25;11(4):e0154012. doi: 10.1371/journal.pone.0154012. eCollection 2016.
PubMed 27111772
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Infections in Children Attending Day Care Centres
- ClinicalTrials.gov ID
- NCT01014676
- Acronym / sponsor ID
- Valio-69
- Keywords
- Costs and Cost Analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Valio LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki
- First posted
- 17 Nov 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.
The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic milk | Active comparator | Dietary Supplement: Probiotic |
| Standard milk | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 2 to 6 years in the beginning of the intervention
- Attendance at a day care centre participating in the study (5 days a week)
Key exclusion criteria (9 listed)
- Milk allergy or lactose intolerance
- Congenital heart diseases that requires regular medication
- Malign diseases
- Cytostatic treatment
- Use of biological rheumatic medication
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 |
|---|---|---|
| Probiotic | Dietary supplement | Probiotic milk |
| Placebo | Other | Standard milk |
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 7 Jul 2011.
- Derived from this study: PubMed 27111772Korpela K, Salonen A, Virta LJ, Kumpu M, Kekkonen RA, de Vos WM. Lactobacillus rhamnosus GG Intake Modifies Preschool Children's Intestinal Microbiota, Alleviates Penicillin-Associated Changes, and Reduces Antibiotic Use. PLoS One. 2016 Apr 25;11(4):e0154012. doi: 10.1371/journal.pone.0154012. eCollection 2016.
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Anne Pitkäranta, Professor principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic in people with Respiratory Tract Infections and Gastrointestinal Diseases, run by Valio Ltd at 1 site in Finland.
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 2 inclusion and 9 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 7 Jul 2011. 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 Finland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT01014676, 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 7 Jul 2011.