DiarrheaNCT01731392
Children Immune Functions(2)
A study testing Milk with Bifidobacteria and Milk with non replicating lactobacilli in people with Diarrhea and Upper Respiratory Infections, run by Société des Produits Nestlé (SPN) at 1 site in Indonesia.
Trial summary
To investigate the effect of milk-based formulas on infections and immune functions in healthy children. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Upper Respiratory Infections
- What is being tested?
- Milk with Bifidobacteria and Milk with non replicating lactobacilli
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2012to Jun 2013
- 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents written and signed informed consent for participation in the study.
- Healthy children aged 1 to 3 years that are no more breastfed.
- Go to a selected nursery and / or pediatrician.
- Parents must have a phone at home or a cellular phone to call the paediatrician.
- No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
- Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.
- Children not being intensive consumers of regular yoghurts
Who cannot join
- Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).
- Used antibiotics within the last 30 days prior to V1 (baseline visit).
- Congenital or chronic disease.
- Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
- Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dept. Nutrition, Faculty of Medicine University of Indonesia
Jakarta
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children
To investigate the effect of milk-based formulas on infections and immune functions in healthy children.
Read the detailed description
Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI.
The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.
- Conditions
- Diarrhea, Upper Respiratory Infections
- Being tested
- Milk with Bifidobacteria, Milk with non replicating lactobacilli, placebo
- Keywords
- Diarrhea, Children, Lactobacilli
- Medical subject headings
- Diarrhea, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk with BifidobacteriaDietary supplement
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
Milk with non replicating lactobacilliDietary supplement
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
placeboDietary supplement
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
| Study group | Role | What they receive |
|---|---|---|
| Milk with Bifidobacteria | Experimental | duration of the treatment is 5 months Receives: Dietary Supplement: Milk with Bifidobacteria |
| Milk with non replicating lactobacilli | Active comparator | duration of the treatment is 5 months Receives: Dietary Supplement: Milk with non replicating lactobacilli |
| Semi skimmed milk | Placebo comparator | duration of the treatment is 5 months Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days with diarrhea
Measured: during the 5 months of follow up
Secondary outcomes (3)
Number of episodes of Upper Respiratory Infections
Measured: 5 months
Duration of episodes of Upper Respiratory Infections
Measured: 5 months
Severity of episodes of Upper Respiratory Infections
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saptawati Bardosono, MSc, Principal investigator, Nutrition Department, Faculty of Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731392
- Sponsor's protocol ID
- 10.50.NRC
- Status last verified
- Dec 2013
- First submitted
- 16 Nov 2012
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children
- ClinicalTrials.gov ID
- NCT01731392
- Acronym / sponsor ID
- 10.50.NRC
- Conditions
- Diarrhea, Upper Respiratory Infections
- Keywords
- Diarrhea, Children, Lactobacilli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Nov 2012 (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.
To investigate the effect of milk-based formulas on infections and immune functions in healthy children.
Detailed description
Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI.
The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk with Bifidobacteria | Experimental | Dietary Supplement: Milk with Bifidobacteriaduration of the treatment is 5 months |
| Milk with non replicating lactobacilli | Active comparator | Dietary Supplement: Milk with non replicating lactobacilliduration of the treatment is 5 months |
| Semi skimmed milk | Placebo comparator | Dietary Supplement: placeboduration of the treatment is 5 months |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parents written and signed informed consent for participation in the study.
- Healthy children aged 1 to 3 years that are no more breastfed.
- Go to a selected nursery and / or pediatrician.
- Parents must have a phone at home or a cellular phone to call the paediatrician.
- No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
Key exclusion criteria (5 listed)
- Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).
- Used antibiotics within the last 30 days prior to V1 (baseline visit).
- Congenital or chronic disease.
- Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
- Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during 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 |
|---|---|---|
| Milk with BifidobacteriaA total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day. | Dietary supplement | Milk with Bifidobacteria |
| Milk with non replicating lactobacilliA total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day. | Dietary supplement | Milk with non replicating lactobacilli |
| placeboA total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day. | Dietary supplement | Semi skimmed milk |
Primary outcome
Days with diarrhea
Time frame: during the 5 months of follow up
3 secondary outcomes
Number of episodes of Upper Respiratory Infections
Time frame: 5 months
Duration of episodes of Upper Respiratory Infections
Time frame: 5 months
Severity of episodes of Upper Respiratory Infections
Time frame: 5 months
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 12 Dec 2013.
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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.
Saptawati Bardosono, MSc principal investigator
Nutrition Department, Faculty of Medicine,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk with Bifidobacteria and Milk with non replicating lactobacilli in people with Diarrhea and Upper Respiratory Infections, run by Société des Produits Nestlé (SPN) at 1 site in Indonesia.
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 7 inclusion and 5 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 12 Dec 2013. 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 Indonesia. 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.
What does the primary outcome measure?
Days with diarrhea (time frame: during the 5 months of follow up). It is what the study was designed to measure, not a finding.
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 12 Dec 2013.