A randomized double-blind, placebo-controlled pilot trial of heat-killed Bifidobacterium bifidum OLB6378 concentrate on fecal IgA levels in children and their parents
Year: 2026
Type: article
Abstract: Objective This pilot study aimed to evaluate the effect of dietary heat-killed Bifidobacterium bifidum OLB6378 concentrate (OLB6378 concentrate) on gut IgA production during childhood and beyond. Results This study was designed as a randomized, double-blind, placebo-controlled pilot trial for children and their parents. After 2-week intake of placebo or OLB6378 drink, an overall analysis with a mixed model for repeated measures showed no significant difference in fecal IgA levels between the groups for children and parents (placebo vs. active: n = 18 vs. n = 15 in children, n = 18 vs. n = 17 in parents). The estimated effect sizes for the change in fecal IgA levels at week 2 were d = 0.32 (95% confidence interval [CI] = − 0.37–1.01) in children and d = − 0.19 (95% CI = − 0.85–0.48) in parents. In conclusion, 2-week supplementation with OLB6378 concentrate did not significantly increase fecal IgA levels in children or parents, although the study provided preliminary feasibility information for designing a future confirmatory trial in children. These findings are hypothesis-generating and provide preliminary data to determine parameter variance and sample size calculations for future larger-scale trials.
Source: BMC Research Notes
Language: English
Subfield: Food Science
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $1,690
OpenAlex ID: W7225876237
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