HealthyNCT01715246
Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)
A study testing Infant Formula in people with Healthy, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.
Trial summary
The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Infant Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2012to Jul 2015
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy babies
- Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
- birth weight between 2500 g- 4500g
- Having obtained the baby's legal representative's informed consent.
- FF groups:
- babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed
- BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.
Who cannot join
- Congenital illness or malformation that may affect growth
- Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
- Minor parent(s)
- Newborn whose parents / caregivers cannot be expected to comply with study procedures
- Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.
- Conditions
- Healthy
- Being tested
- Infant Formula
- Keywords
- healthy babbies, infant formula, growth, HMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
| Study group | Role | What they receive |
|---|---|---|
| Starter infant formula without HMO | Placebo comparator | Volumes of feed depend on age, weight and appetite. Receives: Other: Infant Formula |
| Starter infant formula with 2 HMOs | Active comparator | Volumes of feeds depend on age, weight and appetite Receives: Other: Infant Formula |
| Breasfed reference group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
child growth (body weight) from enrollment to 4 months of age
Measured: 4 months of life
Secondary outcomes (6)
Growth
Measured: 6 and 12 months of age
Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)
Parents are asked to complete a diary on digistive tolerance of their child
Measured: every month during 6 months
Product compliance (quantity of formula in ml consumed on the 3 days before visit)
Parents are asked to complete a diary on the product compliance
Measured: every month for 6 months
Morbidity
Measured: ongoing for 1 year
Stool microbiota
Measured: 3 and 12 months of age
Gene expression
Measured: 3 and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni CORSELLO, Principal investigator, Dipartimento Materno Infantile, PalermoPhilippe ALLIET, Principal investigator, Kinderartsenpraktijk, Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715246
- Sponsor's protocol ID
- 11.26.INF
- Status last verified
- Jul 2014
- First submitted
- 24 Oct 2012
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tarrant I, Finlay BB. Human milk oligosaccharides: potential therapeutic aids for allergic diseases. Trends Immunol. 2023 Aug;44(8):644-661. doi: 10.1016/j.it.2023.06.003. Epub 2023 Jul 11.
PubMed 37438187Dogra SK, Martin FP, Donnicola D, Julita M, Berger B, Sprenger N. Human Milk Oligosaccharide-Stimulated Bifidobacterium Species Contribute to Prevent Later Respiratory Tract Infections. Microorganisms. 2021 Sep 12;9(9):1939. doi: 10.3390/microorganisms9091939.
PubMed 34576834Berger B, Porta N, Foata F, Grathwohl D, Delley M, Moine D, Charpagne A, Siegwald L, Descombes P, Alliet P, Puccio G, Steenhout P, Mercenier A, Sprenger N. Linking Human Milk Oligosaccharides, Infant Fecal Community Types, and Later Risk To Require Antibiotics. mBio. 2020 Mar 17;11(2):e03196-19. doi: 10.1128/mBio.03196-19.
PubMed 32184252Puccio G, Alliet P, Cajozzo C, Janssens E, Corsello G, Sprenger N, Wernimont S, Egli D, Gosoniu L, Steenhout P. Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):624-631. doi: 10.1097/MPG.0000000000001520.
PubMed 28107288
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)
- ClinicalTrials.gov ID
- NCT01715246
- Acronym / sponsor ID
- 11.26.INF
- Conditions
- Healthy
- Keywords
- healthy babbies, infant formula, growth, HMO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Oct 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.
The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Starter infant formula without HMO | Placebo comparator | Other: Infant FormulaVolumes of feed depend on age, weight and appetite. |
| Starter infant formula with 2 HMOs | Active comparator | Other: Infant FormulaVolumes of feeds depend on age, weight and appetite |
| Breasfed reference group | No intervention | – |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy babies
- Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
- birth weight between 2500 g- 4500g
- Having obtained the baby's legal representative's informed consent.
- FF groups:
Key exclusion criteria (5 listed)
- Congenital illness or malformation that may affect growth
- Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
- Minor parent(s)
- Newborn whose parents / caregivers cannot be expected to comply with study procedures
- Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.
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 Formula | Other | Starter infant formula with 2 HMOs, Starter infant formula without HMO |
Primary outcome
Growth
Time frame: 4 months of life
child growth (body weight) from enrollment to 4 months of age
6 secondary outcomes
Growth
Time frame: 6 and 12 months of age
Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)
Time frame: every month during 6 months
Product compliance (quantity of formula in ml consumed on the 3 days before visit)
Time frame: every month for 6 months
Morbidity
Time frame: ongoing for 1 year
Stool microbiota
Time frame: 3 and 12 months of age
Gene expression
Time frame: 3 and 12 months of age
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 11 Sep 2015.
- Derived from this study: PubMed 37438187Tarrant I, Finlay BB. Human milk oligosaccharides: potential therapeutic aids for allergic diseases. Trends Immunol. 2023 Aug;44(8):644-661. doi: 10.1016/j.it.2023.06.003. Epub 2023 Jul 11.
- Derived from this study: PubMed 34576834Dogra SK, Martin FP, Donnicola D, Julita M, Berger B, Sprenger N. Human Milk Oligosaccharide-Stimulated Bifidobacterium Species Contribute to Prevent Later Respiratory Tract Infections. Microorganisms. 2021 Sep 12;9(9):1939. doi: 10.3390/microorganisms9091939.
- Derived from this study: PubMed 32184252Berger B, Porta N, Foata F, Grathwohl D, Delley M, Moine D, Charpagne A, Siegwald L, Descombes P, Alliet P, Puccio G, Steenhout P, Mercenier A, Sprenger N. Linking Human Milk Oligosaccharides, Infant Fecal Community Types, and Later Risk To Require Antibiotics. mBio. 2020 Mar 17;11(2):e03196-19. doi: 10.1128/mBio.03196-19.
- Derived from this study: PubMed 28107288Puccio G, Alliet P, Cajozzo C, Janssens E, Corsello G, Sprenger N, Wernimont S, Egli D, Gosoniu L, Steenhout P. Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):624-631. doi: 10.1097/MPG.0000000000001520.
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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.
Giovanni CORSELLO principal investigator
Dipartimento Materno Infantile, Palermo
Philippe ALLIET principal investigator
Kinderartsenpraktijk, Hasselt, Belgium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with Healthy, run by Société des Produits Nestlé (SPN) at 2 sites in 2 countries.
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 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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.
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?
Growth (time frame: 4 months of life). 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 NCT01715246, which also lists 4 linked publications.
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 11 Sep 2015.