The EFFECT Study: Probiotic and HMO Supplementation in Infants

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.

Inclusion criteria

• Infant is between 0 and 60 days of life at the time of enrollment
• Infant is exclusively formula-fed with caregiver intent to continue exclusive formula feeding for the duration of the study (at least 7 weeks)
• Infant is consuming cow's milk-based formula without probiotics
• Term infant, born >37 weeks gestation
• Infant is healthy and without medical complications
• Infant's caregivers are willing to refrain from feeding their infant breast milk, solid foods, and non-study probiotics prior to study completion

Exclusion criteria

• Infant was born with medical complications such as respiratory distress syndrome or birth defects
• Infant has any gastrointestinal tract abnormalities
• Infant has been diagnosed with failure to thrive
• Infant has taken oral or IV antibiotics or antifungals within 4 weeks of enrollment or during the Lead-in Period
• Infant is consuming partially hydrolyzed or extensively hydrolyzed infant formula because of gastrointestinal disturbance or gassiness/fussiness
• Infant has consumed any breast milk within 7 days of enrollment or during the Lead-in Period
• Infant has consumed any probiotics containing B. infantis since birth
• Infant has consumed any Bifidobacterium-containing probiotics within 2 weeks of enrollment or during the Lead-in Period
• Infant's caregivers plan to feed them any breast milk, solid foods, or non-study probiotics at any time throughout the duration of the study
• Infant was born in a multiple birth
• Infant lives in more than one location
• Any infant who the investigator feels is not an appropriate study participant