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Healthy InfantsNCT04962594

Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s)

A study testing Experimental formulas (EF) and Breast feeding (BF) in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 18 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, controlled, multicenter, double-blind study of healthy term infants. The primary objective of the trial is to demonstrate the safety of a a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth of infants randomized to the experimental formula versus the control… Read more about this study

Who is it for?
Ages 0 to 14 daysHealthy volunteers can take part
Conditions the study is for
Healthy Infants
What is being tested?
Experimental formulas (EF) and Breast feeding (BF)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
18 sitesin 4 countries
Study dates
2 Sep 2021to 4 Apr 2024
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 0 to 14 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
  • Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
  • 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 must meet all of the following inclusion criteria to be eligible for enrollment into the study:
  • Healthy term infant (≥37 weeks of gestation)
Show all 10Show fewer
  • At enrollment visit, post-natal age ≤14 days/0.5 months
  • Birth weight ≥ 2500g and ≤ 4500g.
  • For formula-fed groups, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/LAR must have independently elected, before enrollment, not to breastfeed.
  • For the breastfed group, infants must have been exclusively consuming breast milk since birth, and their parent(s)/LAR must have made the decision to continue exclusively breastfeeding until at least 4 months of age.

Who cannot join

  • Infants with conditions requiring infant feedings other than those specified in the protocol.
  • 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, including:
  • Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)
  • Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
  • Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study. Of note, children who are normally healthy but at the time of enrollment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled.
  • Infants who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool microbiota and characteristics (e.g., oral or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
  • Currently participating or having participated in another clinical trial since birth.
  • Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol

Trial locations and contacts

18 sites in 4 countries.

18 sites in 4 countries

France6 sites

  • CHU Amiens-Picardie

    Amiens, 80054

  • Hôpital Femme Mère Enfant

    Bron, 69677

  • Hôpital de la Croix Rousse

    Lyon, 69004

  • CHU de Nantes

    Nantes

  • CHU Charles Nicolle

    Rouen, 76031

  • Hôpital Bretonneau, CHRU de Tours

    Tours, 37044

Other trials in France

Belgium5 sites

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Kinderartsen Huis

    Hasselt, 3500

  • CHC-Groupe santé, Clinique MontLégia

    Liège, 4000

  • CHU de Liège - CHR de la Citadelle

    Liège, 4000

Other trials in Belgium

Spain5 sites

  • Hospital Vithas Castellón

    Castellon

  • Reina Sofía University Hospital

    Córdoba, 14004

  • Instituto Hispalense de Pediatría, Unidad de Investigación

    Seville, 41014

  • Hospital Vithas Valencia

    Valencia

  • Quironsalud Valencia Hospital

    Valencia

Other trials in Spain

Germany2 sites

  • Klinikum Südstadt Rostock

    Rostock, 18059

  • Evangelisches Waldkrankenhaus Spandau

    Spandau, 13589

Other trials in Germany

About this study

Official title: Safety and Efficacy of Starter Infant Formula, Follow-up Formula and Growing-up Milk Supplemented With Pre- and Probiotic(s): a Double-blind, Randomized, Controlled Trial

This is a randomized, controlled, multicenter, double-blind study of healthy term infants. The primary objective of the trial is to demonstrate the safety of a a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth of infants randomized to the experimental formula versus the control formula from enrolment to 4 months of age.

Read the detailed description

This is a randomized, controlled, multicenter, double-blind study of healthy term infants, consisting of two randomized formula-fed arms (control and experimental formulas) and a non-randomized breast-fed reference group.

The population under investigation are healthy infants aged ≤14 days at enrollment. The planned sample size for formula-fed infants is 236 (118 per study group). A non-randomized breastfed reference group of 90 healthy, term, exclusively breastfed infants up to 4 months will also be enrolled.

Study formulas are administrated orally, ad libitum, from enrollment until 15 months of age.

The primary objective of the trial is to demonstrate the safety of a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth (weight gain, g/day) of infants randomized to the experimental formula versus the control formula from enrolment to 4 months of age.

In addition fecal microbiome, fecal metabolic profile, fecal markers of immune and gut health, blood markers of immune health (in a subset of 60 infants/group), GI tolerance, bone index (subset of 40 infants/group), other anthropometric measurements, dietary pattern and infant illness and infection outcomes will be assessed/measured.

Conditions
Healthy Infants
Being tested
Experimental formulas (EF), Control formulas (CF), Breast feeding (BF)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental formulas (EF)Other

    First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months

  • Control formulas (CF)Other

    First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months

  • Breast feeding (BF)Other

    Exclusive breast feeding up to 4 months

Study groups in NCT04962594
Study groupRoleWhat they receive
Experimental formulas (EF) groupExperimentalStarter infant formula, follow-up infant formula and growing-up milk (partially hydrolyzed bovine whey protein) supplemented with pre- and probiotic(s)
Receives: Other: Experimental formulas (EF)
Control formulas (CF) groupActive comparatorStarter infant formula, follow-up infant formula and growing-up milk (partially hydrolyzed bovine whey protein) not supplemented
Receives: Other: Control formulas (CF)
Breastfed (BF) groupActive comparatorBreast milk
Receives: Other: Breast feeding (BF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Weight gain measured as mean daily weight gain in g/day

    Measured: From baseline (≤14 days) to 4 months of age

Secondary outcomes (22)

  1. Bifidobacteria abundance

    Bifidobacteria abundance

    Measured: At 90 days (3 months of age)

  2. Fecal microbiome

    Overall fecal microbiota composition, diversity, different bacteria taxa and microbiota community types assessed using next generation sequencing (NGS) technology

    Measured: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

  3. Fecal metabolic profile: fecal pH

    Fecal pH

    Measured: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

  4. Fecal metabolic profile: fecal organic acids

    Fecal organic acids (such as, but not restricted to lactate, including indole-lactate, L- and D-lactate, propionate, butyrate, acetate, valerate, and total fecal organic acids)

    Measured: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

  5. Fecal markers of immune health and gut barrier

    Fecal markers of immune health and gut barrier such as total secretory IgA (sIgA), lipocalin-2, calprotectin, and α-1-antitrypsin assessed by ELISA.

    Measured: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

  6. Fecal cytokine profile

    Fecal cytokine profile (such as but not restricted to: IL-6, IL-8, IL-1b, IL-22, IFN-γ) using multiplex assays

    Measured: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

  7. Blood markers of immune health

    Vaccine specific antibodies assessed by ELISA and Immuno-phenotyping in a subset of 120 infants (60/group)

    Measured: At 4 months of age

  8. GI-related behavior: stool frequency

    Stool frequency recorded via the GI Symptom and Behavior Diary

    Measured: Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  9. GI-related behavior: stool consistency

    Stool consistency recorded via the GI Symptom and Behavior Diary

    Measured: Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  10. GI-related behavior: incidence of spitting

    Incidence of spitting recorded via the GI Symptom and Behavior Diary

    Measured: Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  11. GI-related behavior: incidence of flatulence

    Incidence of flatulence via the GI Symptom and Behavior Diary

    Measured: Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  12. GI-related behavior: crying time

    Crying time via the GI Symptom and Behavior Diary

    Measured: Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  13. GI-related behavior: sleep time

    Sleep time via the GI Symptom and Behavior Diary

    Measured: Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  14. GI-related behaviour: volume of formula consumed

    Volume of formula consumed at each feeding or the number of breast milk feedings recorded via the GI Symptom and Behavior Diary

    Measured: Retrospective 1-day (at baseline) and prospective for 3 days prior to 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  15. Infant Gastrointestinal Symptom Index

    GI symptoms via the Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)

    Measured: At baseline, 1, 2, 3, 4, 6, 9, 12 and 15 months of infant age

  16. Bone index

    Bone index measurement will be conducted using a non-invasive and radiation-free ultra-sound sonometer in a subset of 80 children (40/group)

    Measured: At baseline, 3, 6, 9, 12 and 15 months of infant age

  17. Additional growth parameters: weight

    Weight in grams and corresponding weight-for-age Z-score according WHO growth standards

    Measured: At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  18. Additional growth parameters: length

    Length in centimeters and corresponding length-for-age Z-score according WHO growth standards

    Measured: At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  19. Additional growth parameters:head circumference

    Head circumference in centimeters and corresponding head circumference-for-age Z-score according WHO growth standards

    Measured: At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  20. Additional growth parameters: Body Mass Index

    BMI (kg/m2) and corresponding BMI-for-age Z-score according WHO growth standards

    Measured: At infant age ≤14 days (baseline), 1, 2, 3, 4, 6, 9, 12 and 15 months of age

  21. Dietary pattern

    Data collected using a food frequency questionnaire including key food groups for infants and young children

    Measured: At infant age 6, 9, 12 and 15 months

  22. Absenteeism (infant and parent)

    Time away from daycare (infant) or work (parent) will be recorded during occurrences of illness / infection using a calendar-based electronic Infant Illness Diary (IID)

    Measured: Data collected continuously from enrollment until 15 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start2 Sep 2021
  3. Primary completion31 Jul 2023
  4. Study completion4 Apr 2024

Resources

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
Model description
Double-blind, randomized, controlled trial plus a non-randomized breastfed reference group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962594
Sponsor's protocol ID
20.12.INF
Status last verified
Jun 2024
First submitted
5 Jul 2021
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Picaud JC, Claris O, Gil-Campos M, De La Cueva IS, Cornette L, Alliet P, Leke A, Castanet M, Piloquet H, de Halleux V, Mitanchez D, Vandenplas Y, Maton P, Jochum F, Olbertz D, Policarpo SN, Lavalle L, Fumero C, Rodriguez-Garcia P, Moll JM, Silva-Zolezzi I, Zemrani B, Hays NP, Sprenger N, Miranda-Mallea J. Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, B. infantis LMG11588, and B. lactis CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial. Front Nutr. 2025 Jul 23;12:1628847. doi: 10.3389/fnut.2025.1628847. eCollection 2025.

    PubMed 40771223

Questions about this trial

What is this clinical trial studying?

A study testing Experimental formulas (EF) and Breast feeding (BF) in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 18 sites in 4 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 10 inclusion and 8 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Belgium, Spain, Germany. 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?

Weight (time frame: From baseline (≤14 days) to 4 months of age). 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 NCT04962594, 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 13 Jun 2024.

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