Focus on Healthy InfantsNCT01755481
Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate
A study testing Probiotic and Whey protein concentrate in people with Focus on Healthy Infants, run by Arla Foods at 1 site in China.
Trial summary
To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate. Read more about this study
- Who is it for?
- Ages Up to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Focus on Healthy Infants
- What is being tested?
- Probiotic and Whey protein concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Aug 2017
- 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 Up to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days
- healthy infants exclusively breast-fed from birth and mothers intending to breastfeed >80% until at least 5th month of age (meaning through the 4th month of age).
- delivered between 37 and 42 weeks of gestation birth weight >2500 g and <4000 g parent or the subject's legal representative speak and understand Chinese
Who cannot join
- fully or partially breast-fed infants infants breast-fed >20%
- infants fed >20% infant formula
- malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Child Health Care, Children's Hospital, Fudan University
Shanghai
About this study
To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.
- Conditions
- Focus on Healthy Infants
- Being tested
- Probiotic, Whey protein concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Whey protein concentrateOther
| Study group | Role | What they receive |
|---|---|---|
| Probiotics F19 | Experimental | F19 in an infant formula Receives: Other: Probiotic |
| Whey protein concentrate | Experimental | Whey protein concentrate in an infant formula Receives: Other: Whey protein concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infections episodes (gastrointestinal and upper and lower respiratory infections)
Measured: 4 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus on Healthy InfantsStudies 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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arla Foods
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongmei Peng, M.D., Ph.D., Principal investigator, Children's Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755481
- Sponsor's protocol ID
- 327727-2
- Status last verified
- Jan 2018
- First submitted
- 12 Dec 2012
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate
- ClinicalTrials.gov ID
- NCT01755481
- Acronym / sponsor ID
- 327727-2
- Conditions
- Focus on Healthy Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Arla FoodsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 24 Dec 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 evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.
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 |
|---|---|---|
| Probiotics F19 | Experimental | Other: ProbioticF19 in an infant formula |
| Whey protein concentrate | Experimental | Other: Whey protein concentrateWhey protein concentrate in an infant formula |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days
- healthy infants exclusively breast-fed from birth and mothers intending to breastfeed >80% until at least 5th month of age (meaning through the 4th month of age).
- delivered between 37 and 42 weeks of gestation birth weight >2500 g and <4000 g parent or the subject's legal representative speak and understand Chinese
Key exclusion criteria (3 listed)
- fully or partially breast-fed infants infants breast-fed >20%
- infants fed >20% infant formula
- malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics
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 | Other | Probiotics F19 |
| Whey protein concentrate | Other | Whey protein concentrate |
Primary outcome
Infections episodes (gastrointestinal and upper and lower respiratory infections)
Time frame: 4 yrs
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 17 Jan 2018.
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Focus on Healthy Infants
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.
Yongmei Peng, M.D., Ph.D. principal investigator
Children's Hospital, Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Whey protein concentrate in people with Focus on Healthy Infants, run by Arla Foods at 1 site in China.
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 3 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 17 Jan 2018. 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 China. 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. 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?
Infections episodes (gastrointestinal and upper and lower respiratory infections) (time frame: 4 yrs). 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 17 Jan 2018.