Pediatrics category label.GI category label.

Prebiotic Infant Microbiome Study

Human milk oligosaccharides (HMOs) serve as a prebiotic that breeds beneficial bacteria. Most exclusively formula-fed infants lack HMOs in their diet due to the absence of breast milk. This makes colonization of good bacteria (probiotics) difficult.

This study aims to identify a prebiotic concentration that's most effective in creating a healthy gut among formula-fed infants.

Objective

This study seeks to:
1. To assess the ability of prebiotics to initiate colonization of probiotic strains in formula-fed infants.

2. To evaluate the safety and tolerability of prebiotics when delivered in conjunction with a probiotic

Methodology

This is a 7-week decentralized, randomized, and placebo-controlled study of an infant probiotic combined with HMOs and lactoferrin in exclusively formula-fed infants.

Caregivers of 215 healthy infants will be digitally recruited and enrolled into 10 unique treatment arms. Each arm will be assigned a prebiotic supplement varying in amount and type of HMO.

90 participants will be enrolled in phase 1; 125 participants will be enrolled after interim analysis to determine which arms are most apt to colonization.

All study data will be recorded via the ObvioHealth App and DCT Platform. Caregivers will complete daily logs regarding their infants' general health and stool observations and submit regular stool images to a clinical-rater portal for grading by two GI physicians.

Infant stool samples will be collected by caregivers regularly and retrieved by an ObvioHealth logistics partner at the end-of-study.

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