Infant Gut Microbiome Clinical Trial
Official title:
Exclusively Formula-Fed Infants Effectively Colonizing With B. Infantis EVC001 From Lacto-N-Tetraose Supplementation
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.
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.
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Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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