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

NCT04140604 | Completed

• 1 other identifier: GLA-001
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probiotic; Lactobacillus salivarius AP-32; Bifidobacterium animalis subsp. lactis CP-9; Safety; Healthy infant

Outcome Measures

Primary Outcomes (1)

• Mean weight gain.

  The change value from baseline at the end of the treatment.

  15 weeks.

Secondary Outcomes (8)

• Occurrence of adverse events (AEs).

  15 weeks.

• Anthropometric measurements of recumbent length.

  15 weeks.

• Anthropometric measurements of head circumference.

  15 weeks.

• Incidence of regurgitation.

  15 weeks.

• Incidence of flatulence.

  15 weeks.

Study Arms (3)

Lactobacillus salivarius AP-32

EXPERIMENTAL

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

Other: Lactobacillus salivarius AP-32

Bifidobacterium animalis subsp. lactis CP-9

EXPERIMENTAL

A 0.5 g light-yellow capsule containing freeze-dried powder of 2.5 billion CFU of Bifidobacterium animalis subsp. lactis CP-9 and maltodextrin.

Other: Bifidobacterium animalis subsp. lactis CP-9

Placebo

PLACEBO COMPARATOR

The placebo composition and appearance are the same as probiotic capsules, but does not contain live bacteria.

Other: Placebo

Interventions

Lactobacillus salivarius AP-32 OTHER

Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.

Lactobacillus salivarius AP-32

Bifidobacterium animalis subsp. lactis CP-9 OTHER

Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.

Bifidobacterium animalis subsp. lactis CP-9

Placebo OTHER

Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.

Placebo

Eligibility Criteria

• Age: 7 Days - 60 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Having informed consent of the parent or legal guardian.
• Healthy male and female infants between 7 days and 2 months (60 ± 2 days) of age at the time of study initiation.
• Full term ( ≧ 36 weeks gestation at birth).
• Birth weight ≧ 2500 g.
• Able and willing to comply with all study requirements.

You may not qualify if:

• Failure to thrive (weight gain \< 100 grams/week average from birth to the last recorded weight).
• Major acute or chronic illness (e.g. significant cardiac, respiratory, hematological, gastrointestinal or other systemic diseases, major developmental or genetic abnormality).
• Use of substances that alter gut microbiota (antibiotics, prebiotics, probiotics or gastric acid inhibitors) within 2 weeks prior to the study initiation.
• For breastfed infants, use of antibiotics, prebiotics and probiotics by the mothers.
• Cow's milk protein allergy.
• Feeding difficulties.
• History of any allergies to maltodextrin.
• Participation in another clinical trial.
• Any other clinically significant medical, psychiatric and/or social reason as determined by the investigator.

Sponsors & Collaborators

• Hsieh-Hsun Ho: lead

Study Sites (1)

Glac Biotech Co., Ltd

Tainan, 802, Taiwan

Location

Study Officials

• Hsieh-Hsun Ho, Ph.D

  Glac Biotech Co., Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study so neither investigator and site staff, nor the subject know which treatment has been assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: R.D. Senior Manager

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 28, 2019
• Study Start: February 11, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

TW (1)