NCT03939546 (FOUNDATION) is a NA clinical trial of B. infantis EVC001 in Preterm Infant, sponsored by Evolve BioSystems, Inc..

Who is sponsoring NCT03939546?

NCT03939546 is sponsored by Evolve BioSystems, Inc..

What drugs are being tested in NCT03939546?

Interventions in NCT03939546: B. infantis EVC001.

What condition does NCT03939546 study?

NCT03939546 studies Preterm Infant.

Is NCT03939546 still recruiting?

NCT03939546 is currently completed. Last updated 30 June 2021.

Last reviewed 2021-06-30 · How we verify

NCT03939546: FOUNDATION

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

The FOUNDATION Study

Completed NA Last updated 30 June 2021

What this trial tests

NA trial testing B. infantis EVC001 in Preterm Infant in 30 participants. Completed in 1 June 2021.

Timeline

3 July 2019

Primary endpoint
1 June 2021

1 June 2021

Quick facts

Lead sponsor	Evolve BioSystems, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	30
Start date	3 July 2019
Primary completion	1 June 2021
Estimated completion	1 June 2021
Sites	1 location across United States

Drugs / interventions tested

B. infantis EVC001

Conditions studied

Preterm Infant — all drugs for Preterm Infant →

Sponsor

Evolve BioSystems, Inc.

Who can join

Under 10 Days, any sex, with Preterm Infant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

<i>B. infantis</i> EVC001 Is Well-Tolerated and Improves Human Milk Oligosaccharide Utilization in Preterm Infants in the Neonatal Intensive Care Unit.
Bajorek S, Duar RM, Corrigan M, Matrone C, et al · · 2021 · cited 14× · PMID 35071138 · DOI 10.3389/fped.2021.795970

Verify or expand the search:

Other trials of B. infantis EVC001

Trials testing the same drug.

NCT03994315 — The EFFECT Study: Probiotic and HMO Supplementation in Infants · NA · completed
NCT03476447 — Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants · NA · completed

Other recruiting trials for Preterm Infant

Currently open trials in the same condition.

NCT06786039 — Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants · recruiting
NCT06532695 — Development, ADL, Participation, and Quality of Life in Preterm Infants: Longitudinal Research · recruiting
NCT07238231 — Taiwan Preterm Infant Database: Analysis and Comparison of Birth Conditions and Exploration of Prognostic Factors · active not recruiting
NCT03518736 — Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention · NA · active not recruiting
NCT03373721 — Gut Microbiota of Preterm Infants and Full-term Infants at Early Life · recruiting

Other Evolve BioSystems, Inc. trials

Trials by the same sponsor.

NCT05129384 — The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic · NA · terminated
NCT03994315 — The EFFECT Study: Probiotic and HMO Supplementation in Infants · NA · completed
NCT03601936 — User Testing of the Evivo Screening Test · NA · terminated
NCT03476447 — Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants · 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 NCT03939546 (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 Evolve BioSystems, Inc.
Last refreshed: 30 June 2021

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/NCT03939546.

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