NCT05303077 is a NA clinical trial of Nutribén Innova® 1 in Healthy, sponsored by Alter Farmacia, S.A..

Who is sponsoring NCT05303077?

NCT05303077 is sponsored by Alter Farmacia, S.A..

What drugs are being tested in NCT05303077?

Interventions in NCT05303077: Nutribén Innova® 1, Nutribén®, Breastfeed.

Is NCT05303077 still recruiting?

NCT05303077 is currently completed. Last updated 7 April 2022.

Last reviewed 2022-04-07 · How we verify

NCT05303077

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

Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants

Completed NA Last updated 7 April 2022

What this trial tests

NA trial testing Nutribén Innova® 1 in Healthy in 210 participants. Completed in 25 November 2020.

Timeline

11 February 2019

Primary endpoint
25 November 2020

25 November 2020

Quick facts

Lead sponsor	Alter Farmacia, S.A.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	210
Start date	11 February 2019
Primary completion	25 November 2020
Estimated completion	25 November 2020
Sites	21 locations across Spain

Drugs / interventions tested

Nutribén Innova® 1
Nutribén®
Breastfeed

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Alter Farmacia, S.A.

Who can join

Adults 15 Days to 25 Days, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and tolerability of the investigational products (measured as number, frequency and severity of adverse events in all branches of the study)

Publications & conference data

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

Effects of a Novel Infant Formula on Weight Gain, Body Composition, Safety and Tolerability to Infants: The INNOVA 2020 Study.
Plaza-Diaz J, Ruiz-Ojeda FJ, Morales J, de la Torre AIC, et al · · 2022 · cited 16× · PMID 36615804 · DOI 10.3390/nu15010147
Innova 2020: A Follow-Up Study of the Fecal Microbiota of Infants Using a Novel Infant Formula between 6 Months and 12 Months of Age.
Plaza-Diaz J, Ruiz-Ojeda FJ, Morales J, Martín-Masot R, et al · · 2023 · cited 7× · PMID 37108555 · DOI 10.3390/ijms24087392
Effects of a novel infant formula on weight gain and body composition of infants: The INNOVA 2020 study
Plaza-Diaz J, Ruiz-Ojeda FJ, Morales J, de la Torre AIC, et al · · 2022 · DOI 10.1101/2022.10.27.22281417
A multicenter, randomized, blinded, controlled clinical trial investigating the effect of a novel infant formula on the body composition of infants: INNOVA 2020 study protocol
Ruiz-Ojeda FJ, Plaza-Díaz J, Morales J, Cristina de la Torre AI, et al · · 2022 · DOI 10.1101/2022.08.31.22279449

Verify or expand the search:

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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 NCT05303077 (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 Alter Farmacia, S.A.
Last refreshed: 7 April 2022

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/NCT05303077.

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