NCT04962594 is a NA clinical trial of Experimental formulas (EF) in Healthy Infants, sponsored by Société des Produits Nestlé (SPN).

Who is sponsoring NCT04962594?

NCT04962594 is sponsored by Société des Produits Nestlé (SPN).

What drugs are being tested in NCT04962594?

Interventions in NCT04962594: Experimental formulas (EF), Control formulas (CF), Breast feeding (BF).

What condition does NCT04962594 study?

NCT04962594 studies Healthy Infants.

Is NCT04962594 still recruiting?

NCT04962594 is currently completed. Last updated 13 June 2024.

Last reviewed 2024-06-13 · How we verify

NCT04962594

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 13 June 2024

What this trial tests

NA trial testing Experimental formulas (EF) in Healthy Infants in 318 participants. Completed in 4 April 2024.

Timeline

2 September 2021

Primary endpoint
31 July 2023

4 April 2024

Quick facts

Lead sponsor	Société des Produits Nestlé (SPN)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	318
Start date	2 September 2021
Primary completion	31 July 2023
Estimated completion	4 April 2024
Sites	18 locations across Belgium, France, Germany, Spain

Drugs / interventions tested

Experimental formulas (EF)
Control formulas (CF)
Breast feeding (BF)

Conditions studied

Healthy Infants — all drugs for Healthy Infants →

Sponsor

Société des Produits Nestlé (SPN) — full company profile →

Who can join

Adults 0 Days to 14 Days, any sex, with Healthy Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Lipocalin 2-not only a biomarker: a study of current literature and systematic findings of ongoing clinical trials.
Asaf S, Maqsood F, Jalil J, Sarfraz Z, et al · · 2023 · cited 38× · PMID 36529828 · DOI 10.1007/s12026-022-09352-2
Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, <i>B. infantis</i> LMG11588, and <i>B. lactis</i> CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial.
Picaud JC, Claris O, Gil-Campos M, De La Cueva IS, et al · · 2025 · PMID 40771223 · DOI 10.3389/fnut.2025.1628847
ESPGHAN 57th Annual Meeting Abstracts
· 2025
ESPGHAN 56th Annual Meeting Abstracts
· 2024

Verify or expand the search:

Other recruiting trials for Healthy Infants

Currently open trials in the same condition.

NCT07054216 — Probiotic for Infants · NA · recruiting
NCT06789484 — Characterization of the Gastrointestinal Microbiota in Newborn Infants · NA · recruiting

Other Société des Produits Nestlé (SPN) trials

Trials by the same sponsor.

NCT07312201 — Oral Nutritional Supplementation in Children With Growth Concerns · NA · not yet recruiting
NCT07378111 — Vegetarian Tube Feed Study · NA · not yet recruiting
NCT07439718 — The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome · NA · recruiting
NCT07341464 — Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends · NA · recruiting
NCT07127198 — Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04962594 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Société des Produits Nestlé (SPN)
Last refreshed: 13 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04962594.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing