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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140604
• Other study ID #: GLA-001
• Status: Completed
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2023
• Source: Glac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Days to 60 Days

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Safety Issues

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Glac Biotech Co., Ltd	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
Hsieh-Hsun Ho

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean weight gain.	The change value from baseline at the end of the treatment.	15 weeks.
Secondary	Occurrence of adverse events (AEs).	The occurrence of adverse events (AEs) during the period of probiotic or placebo intervention.	15 weeks.
Secondary	Anthropometric measurements of recumbent length.	The change value from baseline at the end of the treatment.	15 weeks.
Secondary	Anthropometric measurements of head circumference.	The change value from baseline at the end of the treatment.	15 weeks.
Secondary	Incidence of regurgitation.	Caregivers will be instructed by the investigator or the designated study center personnel to record the regurgitation for three days within the week before each study visit. At each study visit, the investigator or the designated study center personnel will review the diary and record the times of regurgitation.	15 weeks.
Secondary	Incidence of flatulence.	Caregivers will be instructed by the investigator or the designated study center personnel to record the flatulence for three days within the week before each study visit. At each study visit, the investigator or the designated study center personnel will review the diary and record the times of flatulence.	15 weeks.
Secondary	Incidence of infectious diseases.	Observing the incidence of infectious diseases during the period of probiotic or placebo intervention.	15 weeks.
Secondary	Incidence of allergic diseases.	Observing the incidence of allergic diseases during the period of probiotic or placebo intervention.	15 weeks.
Secondary	Crying and/or fussing time (hours/day) and episodes.	Observing the crying and/or fussing time (hours/day) and episodes during the period of probiotic or placebo intervention.	15 weeks.