Developmental effects on sleep-wake patterns in infants receiving a cow's milk-based infant formula with an added prebiotic blend: a Randomized Controlled Trial

• Published in: Pediatric research Vol. 89; no. 5; pp. 1222 - 1231
• Main Authors: Colombo, John, Carlson, Susan E, Algarín, Cecilia, Reyes, Sussanne, Chichlowski, Maciej, Harris, Cheryl L, Wampler, Jennifer L, Peirano, Patricio, Berseth, Carol Lynn
• Format: Journal Article
• Language: English
• Published: United States Nature Publishing Group 01.04.2021; Nature Publishing Group US
• Subjects: Actigraphy; Animals; Babies; Baby foods; Brain-Gut Axis; Cattle; Clinical; Double-Blind Method; Feces; Female; Galactose - analysis; Gastrointestinal Microbiome; Glucans - chemistry; Hormones; Humans; Hydrocortisone - metabolism; Infant; Infant Formula; Infant, Newborn; Male; Milk - chemistry; Oligosaccharides - chemistry; Prebiotics; Prospective Studies; Saliva - metabolism; Sleep; Wakefulness
• ISSN: 0031-3998; 1530-0447
• DOI: 10.1038/s41390-020-1044-x

Few studies have evaluated nutritive effects of prebiotics on infant behavior state, physiology, or metabolic status. In this double-blind randomized study, infants (n = 161) received cow's milk-based infant formula (Control) or similar formula with an added prebiotic blend (polydextrose and galactooligosaccharides [PDX/GOS]) from 14-35 to 112 days of age. Infant wake behavior (crying/fussing, awake/content) and 24-h sleep-wake actograms were analyzed (Baseline, Days 70 and 112). Salivary cortisol was immunoassayed (Days 70 and 112). In a subset, exploratory stool 16S ribosomal RNA-sequencing was analyzed (Baseline, Day 112). One hundred and thirty-one infants completed the study. Average duration of crying/fussing episodes was similar at Baseline, significantly shorter for PDX/GOS vs. Control at Day 70, and the trajectory continued at Day 112. Latency to first and second nap was significantly longer for PDX/GOS vs. Control at Day 112. Cortisol awakening response was demonstrated at Days 70 and 112. Significant stool microbiome beta-diversity and individual taxa abundance differences were observed in the PDX/GOS group. Results indicate faster consolidation of daytime waking state in infants receiving prebiotics and support home-based actigraphy to assess early sleep-wake patterns. A prebiotic effect on wake organization is consistent with influence on the gut-brain axis and warrants further investigation. Few studies have evaluated nutritive effects of prebiotics on infant behavior state, cortisol awakening response, sleep-wake entrainment, and gut microbiome. Faster consolidation of daytime waking state was demonstrated in infants receiving a prebiotic blend in infant formula through ~4 months of age. Shorter episodes of crying were demonstrated at ~2 months of age (time point corresponding to age/developmental range associated with peak crying) in infants receiving formula with added prebiotics. Results support home-based actigraphy as a suitable method to assess early sleep-wake patterns. Prebiotic effect on wake organization is consistent with influence on the gut-brain axis and warrants further investigation.