NCT03994315

The EFFECT Study: Probiotic and HMO Supplementation in Infants

Exclusively Formula-Fed Infants Effectively Colonizing With B. Infantis EVC001 From Lacto-N-Tetraose Supplementation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Evolve BioSystems, Inc. · Industry
• Sex: All
• Age: 60 Days
• Healthy volunteers: Accepted

Summary

Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial bacteria (bifidobacteria, in particular) in the infant gut. Exclusively formula-fed infants lack HMOs in their diet in the absence of naturally occurring HMOs from breast milk. The proposed clinical study will evaluate the ability of a prebiotic supplement (LNT) to initiate intestinal colonization of a probiotic strain (B. infantis EVC001) in exclusively formula-fed infants. B. infantis EVC001 has been shown to be well-tolerated and safely consumed in breastfed infants. This study also aims to evaluate the safety and tolerability of LNT in different doses when consumed daily with B. infantis EVC001.

Detailed description

This study is a single-center, prospective, randomized, open-label study of an infant probiotic (B. infantis EVC001) and a prebiotic supplement (LNT) in exclusively formula-fed infants. Nine subjects will be enrolled into three treatment arms: * Group 1: 8 x 10\^9 CFU B. infantis + LNT (3 g/L then 8 g/L) * Group 2: 8 x 10\^9 CFU B. infantis + LNT (6 g/L then 12 g/L) * Group 3: 8 x 10\^9 CFU B. infantis alone Study staff will be unblinded to the treatment assignments. Infants in all groups will receive a once-daily oral feeding of B. infantis EVC001 (8.0 x 10\^9 CFU) mixed with infant formula for 28 consecutive days. Two of the treatment groups (Group 1 \& Group 2) will also receive two dose-escalated concentrations of the prebiotic supplement (LNT) mixed with their daily infant formula: Group 1 will receive a concentration of 3 g/L for 2 weeks followed by 8 g/L for the next 2 weeks. Group 2 will receive a concentration of 6 g/L for 2 weeks followed by 12 g/L for the next 2 weeks. Infants consuming the LNT will cross over to the higher dose without a washout period in between. All infants will be evaluated for an additional 2 weeks after cessation of the supplement(s). The total duration of the study will be approximately 7 weeks.

Conditions

• Infant Gut Microbiome

Interventions

Type	Name	Description
OTHER	B. infantis EVC001	Bifidobacterium longum subspecies infantis strain EVC001, designated a "Foods for Special Dietary Use" (FSDU)
OTHER	Lacto-N-tetraose (LNT)	LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis.

Timeline

• Start date: 2019-09-12
• Primary completion: 2020-03-13
• Completion: 2020-03-13
• First posted: 2019-06-21
• Last updated: 2020-07-09

Locations

1 site across 1 country: United States