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

NCT ID: NCT04962594

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-02
• Study Completion Date: 2024-04-04

Brief 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 formula from enrolment to 4 months of age.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental formulas (EF) group

Starter infant formula, follow-up infant formula and growing-up milk (partially hydrolyzed bovine whey protein) supplemented with pre- and probiotic(s)

Group Type: EXPERIMENTAL

Experimental formulas (EF)

Intervention Type: 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) group

Starter infant formula, follow-up infant formula and growing-up milk (partially hydrolyzed bovine whey protein) not supplemented

Group Type: ACTIVE_COMPARATOR

Control formulas (CF)

Intervention Type: 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

Breastfed (BF) group

Breast milk

Group Type: ACTIVE_COMPARATOR

Breast feeding (BF)

Intervention Type: OTHER

Exclusive breast feeding up to 4 months

Interventions

Experimental formulas (EF)

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

Intervention Type: OTHER

Control formulas (CF)

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

Intervention Type: OTHER

Breast feeding (BF)

Exclusive breast feeding up to 4 months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.

3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.

4. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.

1. Healthy term infant (≥37 weeks of gestation)

2. At enrollment visit, post-natal age ≤14 days/0.5 months

3. Birth weight ≥ 2500g and ≤ 4500g.

4. 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.

5. 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.

Exclusion Criteria

1. Infants with conditions requiring infant feedings other than those specified in the protocol.

2. 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:

1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)

2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)

3. 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.

3. 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.

4. Currently participating or having participated in another clinical trial since birth.

5. 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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Sint-Jan Brugge-Oostende AV

Bruges, , Belgium

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Kinderartsen Huis

Hasselt, , Belgium

CHC-Groupe santé, Clinique MontLégia

Liège, , Belgium

CHU de Liège - CHR de la Citadelle

Liège, , Belgium

CHU Amiens-Picardie

Amiens, , France

Hôpital Femme Mère Enfant

Bron, , France

Hôpital de la Croix Rousse

Lyon, , France

CHU de Nantes

Nantes, , France

CHU Charles Nicolle

Rouen, , France

Hôpital Bretonneau, CHRU de Tours

Tours, , France

Klinikum Südstadt Rostock

Rostock, , Germany

Evangelisches Waldkrankenhaus Spandau

Spandau, , Germany

Hospital Vithas Castellón

Castellon, , Spain

Reina Sofía University Hospital

Córdoba, , Spain

Instituto Hispalense de Pediatría, Unidad de Investigación

Seville, , Spain

Hospital Vithas Valencia

Valencia, , Spain

Quironsalud Valencia Hospital

Valencia, , Spain

Countries

Belgium; France; Germany; Spain

References

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.

Reference Type: DERIVED

PMID: 40771223 (View on PubMed)

Other Identifiers

20.12.INF

Identifier Type: -

Identifier Source: org_study_id