NCT00990002: Milk bioactives and immune markers in children

This study investigated blood immune markers in children drinking cow's-milk-based beverages with different bioactive ingredients. Despite “probiotics” in the short title, the registry classifies it as observational, with three cohorts: a control beverage and two beverages containing different ingredients. It should not be relabeled a randomized efficacy trial. 1 2

The planned enrollment was 30 children aged 2–4 years at Boys Town National Research Hospital. The record lists completion in May 2011 but retains anticipated rather than actual enrollment. Children with acute infection, immunodeficiency, recent probiotic use, or relevant milk intolerance were excluded. 1 2

The stated outcomes concern leukocyte populations and serum markers. No verified infection-rate, diarrhea, growth, or clinical-benefit result was retrieved. A change in a blood marker would not independently establish that the beverage prevents illness or “boosts immunity.” 1 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00990002. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00990002. Original study registration: sponsor, design, population, endpoints and dated history.