Trial reportPediatric research2021
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.
Trial report in Pediatric research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Gut Microbiota Modulation as a Therapeutic Strategy for Insomnia: A Systematic Review of Nutritional and Botanical Interventions.Biomolecules · 2026Pooled it
- Effectiveness and safety study of formula containing probiotics, prebiotics, synbiotics on fullterm infants' growth - a systematic review and meta-analysis of randomized controlled study.European journal of clinical nutrition · 2025Pooled it
- Effects of Infant Formula Supplemented With Prebiotics on the Gut Microbiome, Gut Environment, Growth Parameters, and Safety and Tolerance: A Systematic Review and Meta-Analysis.Nutrition reviews · 2025Pooled it
- Development of 24-Hour Rhythms in Cortisol Secretion Across Infancy: A Systematic Review and Meta-Analysis of Individual Participant Data.The Journal of clinical endocrinology and metabolism · 2025Pooled it
- Effects of prebiotics, probiotics, and synbiotics on the infant gut microbiota and other health outcomes: A systematic review.Critical reviews in food science and nutrition · 2023Pooled it
- Effects of Probiotic and Dietary Fiber Supplementation on Metabolic Syndrome-Related Features, Mood, and Sleep in Adults with Obesity.Nutrients · 2026Trial
- Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT.BMC pediatrics · 2026Trial
- Sleep duration among breastfed, goat milk-based or cow's milk-based infant formula-fed infants: Post hoc analyses from a double-blind RCT.Journal of pediatric gastroenterology and nutrition · 2025Trial
- Trial
- Gut Microbiota and Sleep Disorders with a Special Focus on the Pediatric Population.Pediatric reports · 2026Review
- The Gut Microbiome in Sleep Disorders: A Review of Recent Evidence.Actas espanolas de psiquiatria · 2026Review
- Interconnected Developmental Trajectories of the Brain, Gut, and Sleep in Early Life: The First 1000 Days of Nutritional Opportunity.Nutrients · 2026Review
- Leveraging research in early cognitive development for application and impact.Frontiers in developmental psychology · 2026Article
- The gut microbiota and sleep in infants: a focus on diurnal rhythmicity patterns.Gut microbes reports · 2026Article
- Linking gut microbiota rhythmicity to circadian maturation in infants.Scientific reports · 2025Article
- Precision Nutrition and Gut-Brain Axis Modulation in the Prevention of Neurodegenerative Diseases.Nutrients · 2025Review
- Article
- Maturation of infant sleep during the first 6 months of life: a mini-scoping review.Frontiers in neuroscience · 2025Review
- Article
- Probiotics in the New Era of Human Milk Oligosaccharides (HMOs): HMO Utilization and Beneficial Effects ofMicroorganisms · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFew studies have evaluated nutritive effects of prebiotics on infant behavior state, physiology, or metabolic status.
methodsIn 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).
resultsOne 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.
conclusionsResults 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. IMPACT: 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.