Acute Respiratory InfectionNCT01431469
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
A study testing Cow's milk and Follow-On Formula in people with Acute Respiratory Infection and Diarrheal Disease, run by Mead Johnson Nutrition at 1 site in Brazil.
Trial summary
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease. Read more about this study
- Who is it for?
- Ages 12 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Infection, Diarrheal Disease
- What is being tested?
- Cow's milk and Follow-On Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to May 2012
- 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 12 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child 12-48 months of age
- Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
- Signed informed consent
Who cannot join
- Child who is receiving predominantly breast-milk
- Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
- Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
- Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- Child's z-score of weight for length/height < -3 according to World Health Organization criteria
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela
Salvador, Estado de Bahia, CEP 401 10-060
About this study
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
- Conditions
- Acute Respiratory Infection, Diarrheal Disease
- Being tested
- Cow's milk, Follow-On Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow's milkDietary supplement
Powdered Whole Cow's Milk
Follow-On FormulaDietary supplement
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
| Study group | Role | What they receive |
|---|---|---|
| Cow's Milk | Placebo comparator | Powdered Whole Cow's Milk Receives: Dietary Supplement: Cow's milk |
| Follow-On Formula | Experimental | Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide Receives: Dietary Supplement: Follow-On Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of acute respiratory infections and diarrheal disease
Measured: 28 weeks
Secondary outcomes (10)
Occurrence of allergic manifestations
Measured: 28 weeks
Systemic antibiotic use
Measured: 28 weeks
Duration of acute respiratory infection and diarrheal disease
Measured: 28 weeks
Changes in stool patterns
Measured: 28 weeks
Fecal and serum immune markers
Measured: 28 weeks
Serum Ferritin and Zinc status
Measured: 28 weeks
Incidence of stool parasites
Measured: 28 weeks
Growth
Measured: 28 weeks
Incidence of adverse events
The incidence of any adverse event for each participant
Measured: 28 weeks
Acceptance of study product
Acceptance of study product based on quantity consumed
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 2012
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 Acute Respiratory InfectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Bahia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431469
- Sponsor's protocol ID
- 6001
- Status last verified
- Dec 2012
- First submitted
- 31 Aug 2011
- Last updated
- 6 Dec 2012
- Results posted
- No
Publications
Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0.
PubMed 26920136
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
- ClinicalTrials.gov ID
- NCT01431469
- Acronym / sponsor ID
- 6001
- Conditions
- Acute Respiratory Infection, Diarrheal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Bahia
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Sep 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.
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow's Milk | Placebo comparator | Dietary Supplement: Cow's milkPowdered Whole Cow's Milk |
| Follow-On Formula | Experimental | Dietary Supplement: Follow-On FormulaPowdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child 12-48 months of age
- Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
- Signed informed consent
Key exclusion criteria (5 listed)
- Child who is receiving predominantly breast-milk
- Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
- Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
- Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- Child's z-score of weight for length/height < -3 according to World Health Organization criteria
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 |
|---|---|---|
| Cow's milkPowdered Whole Cow's Milk | Dietary supplement | Cow's Milk |
| Follow-On FormulaPowdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide | Dietary supplement | Follow-On Formula |
Primary outcome
Episodes of acute respiratory infections and diarrheal disease
Time frame: 28 weeks
10 secondary outcomes
Occurrence of allergic manifestations
Time frame: 28 weeks
Systemic antibiotic use
Time frame: 28 weeks
Duration of acute respiratory infection and diarrheal disease
Time frame: 28 weeks
Changes in stool patterns
Time frame: 28 weeks
Fecal and serum immune markers
Time frame: 28 weeks
Serum Ferritin and Zinc status
Time frame: 28 weeks
Incidence of stool parasites
Time frame: 28 weeks
Growth
Time frame: 28 weeks
Incidence of adverse events
Time frame: 28 weeks
Acceptance of study product
Time frame: 28 weeks
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 6 Dec 2012.
- Derived from this study: PubMed 26920136Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0.
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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 Cow's milk and Follow-On Formula in people with Acute Respiratory Infection and Diarrheal Disease, run by Mead Johnson Nutrition at 1 site in Brazil.
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 3 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 6 Dec 2012. 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 Brazil. 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?
Episodes of acute respiratory infections and diarrheal disease (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01431469, 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 6 Dec 2012.