Clinical trial NCT04140604: Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Keywords: Probiotic
Lactobacillus salivarius AP-32
Bifidobacterium animalis subsp. lactis CP-9
Safety
Healthy infant
Lead sponsor: Glac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-10-28
Enrollment: 89
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean weight gain.
timeFrame: 15 weeks.
Secondary outcomes:
measure: Occurrence of adverse events (AEs).
timeFrame: 15 weeks.
measure: Anthropometric measurements of recumbent length.
timeFrame: 15 weeks.
measure: Anthropometric measurements of head circumference.
timeFrame: 15 weeks.
measure: Incidence of regurgitation.
timeFrame: 15 weeks.
measure: Incidence of flatulence.
timeFrame: 15 weeks.
measure: Incidence of infectious diseases.
timeFrame: 15 weeks.
measure: Incidence of allergic diseases.
timeFrame: 15 weeks.
measure: Crying and/or fussing time (hours/day) and episodes.
timeFrame: 15 weeks.
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: Glac Biotech Co., Ltd
Study officials:
affiliation: Glac Biotech Co., Ltd
name: Hsieh-Hsun Ho, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: