Infant NutritionNCT01010113
Effects of a Synbiotics-containing Starter Formula on Infant Growth
A study testing Standard infant formula with prebiotics and Infant formula with synbiotics in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.
Trial summary
In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child… Read more about this study
- Who is it for?
- Ages 11 to 17 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- Standard infant formula with prebiotics and Infant formula with synbiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2009to Jun 2011
- 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 11 to 17 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Age at point of enrolment ≤14 days
- Birthweight ≥2500g and ≤4500g
- Full term infant ≥37 weeks gestation and ≤42 weeks gestation
- Singleton births
- Having obtained his/her or his/her legal representative's informed consent
Who cannot join
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal or post-natal disease
- Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.)
- Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment
- Patient who cannot be expected to comply with treatment
- Currently participating or having participated in another clinical trial prior to the beginning of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth of Infants Consuming Starter Formula Containing Synbiotics
In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.
Read the detailed description
Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender.
The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO.
Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.
- Conditions
- Infant Nutrition
- Being tested
- Standard infant formula with prebiotics, Infant formula with synbiotics
- Keywords
- infants, prebiotics, probiotics, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard infant formula with prebioticsOther
From 0-6 months of age. As per standard requirement
Infant formula with synbioticsOther
From 0-6 months of age as per standard requirement
| Study group | Role | What they receive |
|---|---|---|
| Test formula 1 | Placebo comparator | Standard formula with prebiotics Receives: Other: Standard infant formula with prebiotics |
| test product | Experimental | Infant formula with synbiotics Receives: Other: Infant formula with synbiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean weight gain
Measured: 6 months
Secondary outcomes (1)
digestive tolerance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionJun 2011
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 Infant NutritionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Sponsor
- Investigators
- Dr. Lee Le Ye, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010113
- Sponsor's protocol ID
- 09.02 INF
- Status last verified
- Apr 2012
- First submitted
- 5 Nov 2009
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee le Y, Bharani R, Biswas A, Lee J, Tran LA, Pecquet S, Steenhout P. Normal growth of infants receiving an infant formula containing Lactobacillus reuteri, galacto-oligosaccharides, and fructo-oligosaccharide: a randomized controlled trial. Matern Health Neonatol Perinatol. 2015 Apr 7;1:9. doi: 10.1186/s40748-015-0008-3. eCollection 2015.
PubMed 27057326
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth of Infants Consuming Starter Formula Containing Synbiotics
- ClinicalTrials.gov ID
- NCT01010113
- Acronym / sponsor ID
- 09.02 INF
- Conditions
- Infant Nutrition
- Keywords
- infants, prebiotics, probiotics, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 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.
In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.
Detailed description
Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender.
The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO.
Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test formula 1 | Placebo comparator | Other: Standard infant formula with prebioticsStandard formula with prebiotics |
| test product | Experimental | Other: Infant formula with synbioticsInfant formula with synbiotics |
Who may qualify
- Ages
- 11 to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy newborn infant
- Age at point of enrolment ≤14 days
- Birthweight ≥2500g and ≤4500g
- Full term infant ≥37 weeks gestation and ≤42 weeks gestation
- Singleton births
Key exclusion criteria (6 listed)
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal or post-natal disease
- Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.)
- Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment
- Patient who cannot be expected to comply with treatment
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 |
|---|---|---|
| Standard infant formula with prebioticsFrom 0-6 months of age. As per standard requirement | Other | Test formula 1 |
| Infant formula with synbioticsFrom 0-6 months of age as per standard requirement | Other | test product |
Primary outcome
mean weight gain
Time frame: 6 months
1 secondary outcome
digestive tolerance
Time frame: 6 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 23 Apr 2012.
- Derived from this study: PubMed 27057326Lee le Y, Bharani R, Biswas A, Lee J, Tran LA, Pecquet S, Steenhout P. Normal growth of infants receiving an infant formula containing Lactobacillus reuteri, galacto-oligosaccharides, and fructo-oligosaccharide: a randomized controlled trial. Matern Health Neonatol Perinatol. 2015 Apr 7;1:9. doi: 10.1186/s40748-015-0008-3. eCollection 2015.
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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.
Dr. Lee Le Ye, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard infant formula with prebiotics and Infant formula with synbiotics in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.
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 6 inclusion and 6 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 23 Apr 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 Singapore. 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?
mean weight gain (time frame: 6 months). 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 NCT01010113, 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 23 Apr 2012.