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

NCT04962594 | Completed

• 1 other identifier: 20.12.INF
• Study Type: interventional
• Target: 318
• Locations: 4 countries
• Sites: 18

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.

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (1)

• Weight

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

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

Secondary Outcomes (22)

• Bifidobacteria abundance

  At 90 days (3 months of age)

• Fecal microbiome

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

• Fecal metabolic profile: fecal pH

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

• Fecal metabolic profile: fecal organic acids

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

• Fecal markers of immune health and gut barrier

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

Study Arms (3)

Experimental formulas (EF) group

EXPERIMENTAL

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

Other: Experimental formulas (EF)

Control formulas (CF) group

ACTIVE COMPARATOR

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

Other: Control formulas (CF)

Breastfed (BF) group

ACTIVE COMPARATOR

Breast milk

Other: Breast feeding (BF)

Interventions

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

Experimental formulas (EF) group

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

Control formulas (CF) group

Breast feeding (BF) OTHER

Exclusive breast feeding up to 4 months

Breastfed (BF) group

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (18)

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Kinderartsen Huis

Hasselt, 3500, Belgium

Location

CHC-Groupe santé, Clinique MontLégia

Liège, 4000, Belgium

Location

CHU de Liège - CHR de la Citadelle

Liège, 4000, Belgium

Location

CHU Amiens-Picardie

Amiens, 80054, France

Location

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

CHU de Nantes

Nantes, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

Hôpital Bretonneau, CHRU de Tours

Tours, 37044, France

Location

Klinikum Südstadt Rostock

Rostock, 18059, Germany

Location

Evangelisches Waldkrankenhaus Spandau

Spandau, 13589, Germany

Location

Hospital Vithas Castellón

Castellon, Spain

Location

Reina Sofía University Hospital

Córdoba, 14004, Spain

Location

Instituto Hispalense de Pediatría, Unidad de Investigación

Seville, 41014, Spain

Location

Hospital Vithas Valencia

Valencia, Spain

Location

Quironsalud Valencia Hospital

Valencia, Spain

Location

Related Publications (1)

• 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.

  PMID: 40771223 DERIVED

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unique coding of the study products
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, controlled trial plus a non-randomized breastfed reference group

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 15, 2021
• Study Start: September 2, 2021
• Primary Completion: July 31, 2023
• Study Completion: April 4, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); BE (5); ES (5); DE (2)