NCT03422562 is a Phase 3 clinical trial of Florababy in Microbial Colonization, sponsored by Belal Alshaikh.

Who is sponsoring NCT03422562?

NCT03422562 is sponsored by Belal Alshaikh.

What drugs are being tested in NCT03422562?

Interventions in NCT03422562: Florababy.

What condition does NCT03422562 study?

NCT03422562 studies Microbial Colonization.

Is NCT03422562 still recruiting?

NCT03422562 is currently completed. Last updated 11 January 2022.

Last reviewed 2022-01-11 · How we verify

NCT03422562

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

Probiotics and Intestinal Microbiome in Preterm Infants

Completed Phase 3 Last updated 11 January 2022

What this trial tests

Phase 3 trial testing Florababy in Microbial Colonization in 62 participants. Completed in 26 April 2021.

Timeline

26 October 2017

Primary endpoint
30 March 2020

26 April 2021

Quick facts

Lead sponsor	Belal Alshaikh
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	62
Start date	26 October 2017
Primary completion	30 March 2020
Estimated completion	26 April 2021
Sites	1 location across Canada

Drugs / interventions tested

Florababy — full drug profile →

Conditions studied

Microbial Colonization — all drugs for Microbial Colonization →

Sponsor

Belal Alshaikh

Who can join

Adults 23 Weeks to 29 Weeks, any sex, with Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants. Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and \< 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.

Publications & conference data

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

Multi-strain probiotics for extremely preterm infants: a randomized controlled trial.
Alshaikh B, Samara J, Moossavi S, Ferdous T, et al · · 2022 · cited 21× · PMID 35314794 · DOI 10.1038/s41390-022-02004-z

Verify or expand the search:

Other recruiting trials for Microbial Colonization

Currently open trials in the same condition.

NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
NCT06805994 — Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment · Phase 1 · recruiting
NCT06938386 — Pilot Haskap Metabolite Timing Project · NA · active not recruiting
NCT06920641 — Effects of Tagatose on Glycemic Response and Gastrointestinal Microbiota in Healthy Adults · NA · recruiting
NCT06541808 — Balance, Autonomic Response, and Sensory Modulation to Dosage of Mechanical Vagal Stimulation in Healthy Adults · NA · recruiting

Other Belal Alshaikh trials

Trials by the same sponsor.

NCT03708068 — Early Exclusive Enteral Nutrition in Early Preterm Infants · NA · completed
NCT03637413 — Effect of Hindmilk on Growth Velocity of Very Preterm Infants · NA · unknown
NCT03594474 — Early Higher Intravenous Lipid Intake in VLBW 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 NCT03422562 (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 Belal Alshaikh
Last refreshed: 11 January 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/NCT03422562.

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