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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
89
Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
Glac Biotech Co., Ltd
Tainan, Taiwan
Mean weight gain.
The change value from baseline at the end of the treatment.
Time frame: 15 weeks.
Occurrence of adverse events (AEs).
The occurrence of adverse events (AEs) during the period of probiotic or placebo intervention.
Time frame: 15 weeks.
Anthropometric measurements of recumbent length.
The change value from baseline at the end of the treatment.
Time frame: 15 weeks.
Anthropometric measurements of head circumference.
The change value from baseline at the end of the treatment.
Time frame: 15 weeks.
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.
Time frame: 15 weeks.
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.
Time frame: 15 weeks.
Incidence of infectious diseases.
Observing the incidence of infectious diseases during the period of probiotic or placebo intervention.
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Time frame: 15 weeks.
Incidence of allergic diseases.
Observing the incidence of allergic diseases during the period of probiotic or placebo intervention.
Time frame: 15 weeks.
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.
Time frame: 15 weeks.