Infants GrowthPhase 3NCT01886898
Synbiotics and Growth
A Phase 3 study testing Infant formula and Breastfeeding in people with Infants Growth, run by Société des Produits Nestlé (SPN) at 1 site in Italy.
Trial summary
The primary objective of the trial is to assess the growth of the infants enrolled into the study. Other parameters to be measured include microbiota balance and certain blood biochemical values. In addition the infants' digestive tolerance of the formulae and frequency of morbidity will be investigated. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Infants Growth
- What is being tested?
- Infant formula and Breastfeeding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2007to Oct 2009
- 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy new-born infant
- Infant is less14 days old on day of enrollment
- Birthweight between 2500g and 4500g
- Gestational age over 37 weeks
- Singleton birth
- Infant's mother, before the 14th day of the child's life, has elected not to breastfeed
- Infant randomized in to a treatment group can expected to be exclusively fed the formula from enrolment until 16 weeks old
- Having obtained his/her legal representative's informed consent
Who cannot join
- Currently participating in another clinical trial
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
- Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
- Receiving antibiotic treatment at time of enrolment or in the 5 previous days.
- Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth of Infants Fed Starter Formula Containing Oligo-saccharides and the Probiotics Bifidobacterium & Lactobacillus
The primary objective of the trial is to assess the growth of the infants enrolled into the study. Other parameters to be measured include microbiota balance and certain blood biochemical values. In addition the infants' digestive tolerance of the formulae and frequency of morbidity will be investigated.
Read the detailed description
The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. The treatment period, in terms of data necessary for the primary outcome, will be until they reach 16 weeks old. Growth and other measurements will be collected on five separate occasions during this period, ie 2, 4, 8, 12 and 16 weeks of life. Although the study intervention formally ends at 16 weeks, it will be useful to have a follow up visit at 26 weeks to collect further data on the gut microflora in the sub-group of infants who have already provided a stool sample at 8 weeks. This follow-up visit will be of benefit to the subject as they receive a weight check and clinical examination by a paediatrician and will be offered to all subjects (no invasive procedures will be carried out).
- Conditions
- Infants Growth
- Being tested
- Infant formula, Breastfeeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
infant formula
BreastfeedingOther
| Study group | Role | What they receive |
|---|---|---|
| Standard starter infant formula | Placebo comparator | starter infant formula from enrollment till 16 weeks of age Receives: Other: Infant formula |
| starter infant formula with prebiotics | Experimental | starter infant formula from enrollment till 16 weeks of age Receives: Other: Infant formula |
| starter infant formula with pro and prebiotics | Experimental | starter infant formula from enrollment till 16 weeks of age Receives: Other: Infant formula |
| breastfeeding group | Other | exclusively breastfeeding during the first 16 weeks of age Receives: Other: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean weight gain (g/day)
Measured: over 16 weeks
Secondary outcomes (2)
length (cm), head circumference (cm)
Measured: over 1 year
• digestive tolerance (stool characteristics and frequency, vomiting, spitting up, frequency of colic)
Measured: over 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionOct 2009
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 Infants GrowthStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886898
- Sponsor's protocol ID
- 05.23.INF
- Status last verified
- Jun 2013
- First submitted
- 24 Jun 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Meli F, Puccio G, Cajozzo C, Ricottone GL, Pecquet S, Sprenger N, Steenhout P. Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial. BMC Pediatr. 2014 Dec 20;14:306. doi: 10.1186/s12887-014-0306-3.
PubMed 25527244
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth of Infants Fed Starter Formula Containing Oligo-saccharides and the Probiotics Bifidobacterium & Lactobacillus
- ClinicalTrials.gov ID
- NCT01886898
- Acronym / sponsor ID
- 05.23.INF
- Conditions
- Infants Growth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Jun 2013 (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 primary objective of the trial is to assess the growth of the infants enrolled into the study. Other parameters to be measured include microbiota balance and certain blood biochemical values. In addition the infants' digestive tolerance of the formulae and frequency of morbidity will be investigated.
Detailed description
The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. The treatment period, in terms of data necessary for the primary outcome, will be until they reach 16 weeks old. Growth and other measurements will be collected on five separate occasions during this period, ie 2, 4, 8, 12 and 16 weeks of life. Although the study intervention formally ends at 16 weeks, it will be useful to have a follow up visit at 26 weeks to collect further data on the gut microflora in the sub-group of infants who have already provided a stool sample at 8 weeks. This follow-up visit will be of benefit to the subject as they receive a weight check and clinical examination by a paediatrician and will be offered to all subjects (no invasive procedures will be carried out).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard starter infant formula | Placebo comparator | Other: Infant formulastarter infant formula from enrollment till 16 weeks of age |
| starter infant formula with prebiotics | Experimental | Other: Infant formulastarter infant formula from enrollment till 16 weeks of age |
| starter infant formula with pro and prebiotics | Experimental | Other: Infant formulastarter infant formula from enrollment till 16 weeks of age |
| breastfeeding group | Other | Other: Breastfeedingexclusively breastfeeding during the first 16 weeks of age |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy new-born infant
- Infant is less14 days old on day of enrollment
- Birthweight between 2500g and 4500g
- Gestational age over 37 weeks
- Singleton birth
Key exclusion criteria (6 listed)
- Currently participating in another clinical trial
- Congenital illness or malformation that may affect normal growth
- Significant pre-natal and/or post-natal disease
- Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
- Receiving antibiotic treatment at time of enrolment or in the 5 previous days.
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 |
|---|---|---|
| Infant formulainfant formula | Other | Standard starter infant formula, starter infant formula with prebiotics, starter infant formula with pro and prebiotics |
| Breastfeeding | Other | breastfeeding group |
Primary outcome
mean weight gain (g/day)
Time frame: over 16 weeks
2 secondary outcomes
length (cm), head circumference (cm)
Time frame: over 1 year
• digestive tolerance (stool characteristics and frequency, vomiting, spitting up, frequency of colic)
Time frame: over 4 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 26 Jun 2013.
- Derived from this study: PubMed 25527244Meli F, Puccio G, Cajozzo C, Ricottone GL, Pecquet S, Sprenger N, Steenhout P. Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial. BMC Pediatr. 2014 Dec 20;14:306. doi: 10.1186/s12887-014-0306-3.
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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 Phase 3 study testing Infant formula and Breastfeeding in people with Infants Growth, run by Société des Produits Nestlé (SPN) at 1 site in Italy.
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 8 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 26 Jun 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 Italy. 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.
What does the primary outcome measure?
mean weight gain (g/day) (time frame: over 16 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 NCT01886898, 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 26 Jun 2013.