HealthyNCT03090360
Growth of Infants Fed a New Term Infant Formula
A study testing Infant formula (CF) and Infant Formula (EF) in people with Healthy, run by Société des Produits Nestlé (SPN) at 7 sites in 2 countries.
Trial summary
To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk 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 (CF) and Infant Formula (EF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 21 Feb 2017to 21 May 2019
- 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
- Written informed consent signed and dated
- Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
- Infants whose parent(s)/LAR have a working freezer.
- Healthy term, singleton infant at birth.
Show all 9Show fewer
- At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
- At enrollment, birth weight ≥ 2500g and ≤ 4500g.
- For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.
Who cannot join
- Infants with conditions requiring infant feedings other than those specified in the protocol.
- Infants receiving complementary foods or liquids.
- Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.
- Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
- Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Belgium5 sites
Algemeen Stedelijk Ziekenhuis Aalst
Aalst
UZ Brussel
Brussels
Kinderartsen Huis5
Hasselt, 3500
Clinique Ste Elisabeth
Namur
CHwapi
Tournai
Italy2 sites
Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico
Milan
AOUP "Paolo Giaccone"
Palermo
About this study
Official title: Growth of Infants Fed a New Term Infant Formula With a Prebiotic
To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk
Read the detailed description
Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.
- Conditions
- Healthy
- Being tested
- Infant formula (CF), Infant Formula (EF)
- Keywords
- Healthy babies, Infant formula, Growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula (CF)Dietary supplement
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
Infant Formula (EF)Dietary supplement
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo comparator (Control) | Placebo comparator | Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite. Receives: Dietary Supplement: Infant formula (CF) |
| Experimental Formula (Test) | Experimental | Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite. Receives: Dietary Supplement: Infant Formula (EF) |
| Breastfed reference group | No intervention | Breastfed reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Growth (weight gain velocity)
Measured: 120 days
Secondary outcomes (7)
Growth
Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group
Measured: Every month up to 6 months of age
Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)
Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)
Measured: Every month up to 6 months of age
GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake)
GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake)
Measured: Every month up to 6 months of age
Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)
Fecal microbiota composition, diversity, and abundance
Measured: Every month up to 4 months of age
Fecal markers (pH, fecal organic acids, and protein markers of gut health)
Fecal markers (pH, fecal organic acids, and protein markers of gut health)
Measured: Every month up to 4 months of age
Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)
Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)
Measured: Up to 3 months of age
Adverse events / Morbidity
Adverse events / Morbidity
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start21 Feb 2017
- Primary completion11 Apr 2019
- Study completion21 May 2019
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Alliet, Principal investigator, Kinderartsen Huis 5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090360
- Sponsor's protocol ID
- 16.07.INF
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alliet P, Vandenplas Y, Roggero P, Jespers SNJ, Peeters S, Stalens JP, Kortman GAM, Amico M, Berger B, Sprenger N, Cercamondi CI, Corsello G. Safety and efficacy of a probiotic-containing infant formula supplemented with 2'-fucosyllactose: a double-blind randomized controlled trial. Nutr J. 2022 Feb 22;21(1):11. doi: 10.1186/s12937-022-00764-2.
PubMed 35193609
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth of Infants Fed a New Term Infant Formula With a Prebiotic
- ClinicalTrials.gov ID
- NCT03090360
- Acronym / sponsor ID
- 16.07.INF
- Conditions
- Healthy
- Keywords
- Healthy babies, Infant formula, Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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 growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk
Detailed description
Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo comparator (Control) | Placebo comparator | Dietary Supplement: Infant formula (CF)Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite. |
| Experimental Formula (Test) | Experimental | Dietary Supplement: Infant Formula (EF)Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite. |
| Breastfed reference group | No intervention | –Breastfed reference group |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Written informed consent signed and dated
- Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
- Infants whose parent(s)/LAR have a working freezer.
Key exclusion criteria (5 listed)
- Infants with conditions requiring infant feedings other than those specified in the protocol.
- Infants receiving complementary foods or liquids.
- Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.
- Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
- Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
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 (CF)Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days. | Dietary supplement | Placebo comparator (Control) |
| Infant Formula (EF)Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days. | Dietary supplement | Experimental Formula (Test) |
Primary outcome
Growth
Time frame: 120 days
Growth (weight gain velocity)
7 secondary outcomes
Growth
Time frame: Every month up to 6 months of age
Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)
Time frame: Every month up to 6 months of age
GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake)
Time frame: Every month up to 6 months of age
Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)
Time frame: Every month up to 4 months of age
Fecal markers (pH, fecal organic acids, and protein markers of gut health)
Time frame: Every month up to 4 months of age
Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)
Time frame: Up to 3 months of age
Adverse events / Morbidity
Time frame: 180 days
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 5 Jul 2019.
- Derived from this study: PubMed 35193609Alliet P, Vandenplas Y, Roggero P, Jespers SNJ, Peeters S, Stalens JP, Kortman GAM, Amico M, Berger B, Sprenger N, Cercamondi CI, Corsello G. Safety and efficacy of a probiotic-containing infant formula supplemented with 2'-fucosyllactose: a double-blind randomized controlled trial. Nutr J. 2022 Feb 22;21(1):11. doi: 10.1186/s12937-022-00764-2.
- Individual participant dataSharing planned: No
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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.
Philippe Alliet principal investigator
Kinderartsen Huis 5
7 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 (CF) and Infant Formula (EF) in people with Healthy, run by Société des Produits Nestlé (SPN) at 7 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 9 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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: 120 days). 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 NCT03090360, 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 5 Jul 2019.