NCT05952076

Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Bi-26 (Strain of Bifidobacterium Longum, B. Infantis) Supplementation Versus Placebo on Weight Gain in Underweight Infants

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 30 Days – 120 Days
• Healthy volunteers: Not accepted

Summary

The burden of disease experienced by underweight children is significant, particularly in low- and middle-income countries. Gut dysbiosis, an imbalance in microbial composition, is thought to play a role in nutrient malabsorption leading to underweight infants and failure to thrive. Bifidobacterium longum subspecies infantis (B. infantis) is a commensal bacterial strain important in the breakdown of human milk oligosaccharides (HMOs). A decrease in abundance or absence of B. infantis could lead to inadequate HMO processing, elevating intestinal pH and increasing the risk of pathogen overgrowth. Bi-26 is a B. infantis probiotic strain that is being evaluated in this study for its impact on weight gain and other health outcomes in underweight infants.

Conditions

• Underweight
• Paediatrics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B. infantis Bi-26	A once-daily oral dose of Bi-26 will be provided to infants for 28 days.
DIETARY_SUPPLEMENT	Placebo	A once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days

Timeline

• Start date: 2023-07-03
• Primary completion: 2023-12-26
• Completion: 2024-01-29
• First posted: 2023-07-19
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

5 sites across 1 country: Pakistan