- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140604
Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cheng-Hsun Chiu, M.D.,Ph.D
- Phone Number: 8284 +886+3+3281200
- Email: chchiu@adm.cgmh.org.tw
Study Contact Backup
- Name: Hsieh-Hsun Ho, Ph.D
- Phone Number: 230 +886+6+5891876
- Email: sam.ho@glact.com.tw
Study Locations
-
-
-
Tainan City, Taiwan, 802
- Glac Biotech Co., Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
The placebo composition and appearance are the same as probiotic capsules, but does not contain live bacteria.
|
Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
|
Experimental: Lactobacillus salivarius AP-32
A 0.5 g light-yellow capsule containing freeze-dried powder of 2.5 billion CFU of Lactobacillus salivarius AP-32 and maltodextrin.
|
Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
|
Experimental: Bifidobacterium animalis subsp. lactis CP-9
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.
|
Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean weight gain.
Time Frame: 15 weeks.
|
The change value from baseline at the end of the treatment.
|
15 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of adverse events (AEs).
Time Frame: 15 weeks.
|
The occurrence of adverse events (AEs) during the period of probiotic or placebo intervention.
|
15 weeks.
|
Anthropometric measurements of recumbent length.
Time Frame: 15 weeks.
|
The change value from baseline at the end of the treatment.
|
15 weeks.
|
Anthropometric measurements of head circumference.
Time Frame: 15 weeks.
|
The change value from baseline at the end of the treatment.
|
15 weeks.
|
Incidence of regurgitation.
Time Frame: 15 weeks.
|
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.
|
Incidence of flatulence.
Time Frame: 15 weeks.
|
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.
|
Incidence of infectious diseases.
Time Frame: 15 weeks.
|
Observing the incidence of infectious diseases during the period of probiotic or placebo intervention.
|
15 weeks.
|
Incidence of allergic diseases.
Time Frame: 15 weeks.
|
Observing the incidence of allergic diseases during the period of probiotic or placebo intervention.
|
15 weeks.
|
Crying and/or fussing time (hours/day) and episodes.
Time Frame: 15 weeks.
|
Observing the crying and/or fussing time (hours/day) and episodes during the period of probiotic or placebo intervention.
|
15 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hsieh-Hsun Ho, Ph.D, Glac Biotech Co., Ltd
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GLA-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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