NCT04140604

Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.

A Three-arm, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 Used Individually in Healthy Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Hsieh-Hsun Ho · Industry
• Sex: All
• Age: 7 Days – 60 Days
• Healthy volunteers: Accepted

Summary

This is a three-arm, double-blind, placebo-controlled study to investigate the safety of Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used individually in healthy infants. Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.

Detailed description

This is a three-arm, double-blind, placebo-controlled study to investigate the safety of Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used individually in healthy infants. Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks. Follow-up visits will take place at study days 14±3, 42±3, 70±4 and 105±4. Caregivers will keep a diary of the volume of formula intake/minutes of breastfeeding, stool frequency and consistency (hard, formed, soft/paste or loose/watery), symptoms of digestive tolerance (regurgitation and flatulence), sleeping time, crying/fussing time and episodes for 3 days before each visit. At each visit, the research team will review the diary and conduct physical examination, including anthropometric measurements (weight, recumbent length, and head circumference). Fecal samples will be collected prior to the first administration of the assigned study product and at the end of study for microbiota analysis. Adverse events (AEs) will be assessed based on inquires to the caregivers. AEs will be classified as related or unrelated based on a relationship to study product intake according to the investigator.

Conditions

• Safety Issues

Interventions

Type	Name	Description
OTHER	Lactobacillus salivarius AP-32	Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
OTHER	Bifidobacterium animalis subsp. lactis CP-9	Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
OTHER	Placebo	Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.

Timeline

• Start date: 2020-02-11
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2019-10-28
• Last updated: 2023-07-19

Locations

1 site across 1 country: Taiwan