What question did this study set out to answer?

This trial aims to determine whether B. infantis strain Bi-26 supplementation affects growth and health outcomes in underweight infants.

May 3, 2026Frontiers in Nutrition0 citationsOpen Access

Impact of Bifidobacterium infantis supplementation on growth, health outcomes, and gut microbiome features in underweight infants from Pakistan

JPJanie ParrinoGroupe d'Analyse et de Théorie Economique Lyon St Etienne JSJustine SunshineGroupe d'Analyse et de Théorie Economique Lyon St Etienne KTKenneth TrippGroupe d'Analyse et de Théorie Economique Lyon St Etienne

Key Points

This trial aims to determine whether B. infantis strain Bi-26 supplementation affects growth and health outcomes in underweight infants.
Conducted as a double-blind, randomized, placebo-controlled trial with 40 infants aged 30–120 days.
Participants received daily oral Bi-26 or placebo for 28 days, with follow-up to day 90 for safety assessment.
Total B. infantis levels, microbiome, metabolome, and cytokine profiles were assessed.
Bi-26 supplementation increased fecal B. infantis levels at day 28 (p = 0.001) and day 56 (p = 0.03).
No significant change in weight-for-age Z score (WAZ) (p = 0.69) or weight gain (p = 0.56) compared to placebo.
Fewer adverse events (AEs) occurred in the Bi-26 group (40% vs. 80%), suggesting a better safety profile.

Abstract

Background Alterations in the gut microbiome are implicated in infant malnutrition. Bifidobacterium longum subspecies infantis ( B. infantis ), a commensal common in breastfed infants, has been shown to have reduced abundance in malnourished infants. This trial (NCT05952076) evaluated if B. infantis strain Bi-26 supplementation could improve growth and health outcomes in underweight infants in Pakistan. Methods In this double-blind, randomized, placebo-controlled trial, 40 infants aged 30–120 days (d) with a weight-for-age Z score (WAZ) below −2 received daily oral Bi-26 or placebo for 28d, with follow-up to d90 for safety. The primary endpoint was change in WAZ from baseline to d56. The intended sample size was 396 infants but study was terminated early due to operational delays. Total B. infantis levels microbiome, metabolome, and cytokine profiles were assessed. Results Bi-26 supplementation increased fecal B. infantis levels at d28 ( p = 0.001) and d56 ( p = 0.03) but did not result in significant change in WAZ ( p = 0.69) or weight gain ( p = 0.56) compared to placebo. Fewer adverse events (AEs) occurred in the Bi-26 group compared to placebo (40% vs. 80% of infants; 17 vs. 49 events). Probiotic engraftment was impacted by presence of baseline endogenous B. infantis , suggesting that Bi-26 complemented rather than outcompeted endogenous strains. Bi-26 altered microbiome composition with transient alterations in function and metabolite abundance that reverted to baseline by d56, without cytokine differences between groups. B. infantis levels and Bifidobacterium-community types were associated with fewer AEs but not changes in WAZ or weight. Discussion Bi-26 supplementation had an acceptable safety profile but did not improve growth. The findings of this trial support further evaluation of B. infantis strains in larger studies of underweight infants across diverse LMIC settings. Future trials should determine whether sustained metabolic and functional remodeling can translate into measurable improvements in growth and health outcomes. Clinical trial registration https://www.clinicaltrials.gov/study/NCT05952076 , NCT05952076.

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