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

NCT04140604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2023-07-19

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

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.

Sponsors & Collaborators

  • Hsieh-Hsun Ho

    lead INDUSTRY

Principal Investigators

  • Hsieh-Hsun Ho, Ph.D · Glac Biotech Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
60 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04140604 on ClinicalTrials.gov