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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-11

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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

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Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active:

1. Lactobacillus salivarius AP-32.
2. Bifidobacterium animalis subsp. lactis CP-9. supplied as 0.5 g capsules.

Placebo:

The placebo capsules are identical to the Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 capsules except for the probiotics.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

This is a double-blind study so neither investigator and site staff, nor the subject know which treatment has been assigned.

Study Groups

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Lactobacillus salivarius AP-32

A 0.5 g light-yellow capsule containing freeze-dried powder of 2.5 billion CFU of Lactobacillus salivarius AP-32 and maltodextrin.

Group Type EXPERIMENTAL