Safety IssuesNCT04140604
Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.
A study testing Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 in people with Safety Issues, run by Hsieh-Hsun Ho at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 7 to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Feb 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- Lactobacillus salivarius AP-32, Bifidobacterium animalis subsp. lactis CP-9, Placebo
- Keywords
- Probiotic, Lactobacillus salivarius AP-32, Bifidobacterium animalis subsp. lactis CP-9, Safety, Healthy infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus salivarius AP-32Other
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-9Other
Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean weight gain.
The change value from baseline at the end of the treatment.
Measured: 15 weeks.
Secondary outcomes (8)
Occurrence of adverse events (AEs).
The occurrence of adverse events (AEs) during the period of probiotic or placebo intervention.
Measured: 15 weeks.
Anthropometric measurements of recumbent length.
The change value from baseline at the end of the treatment.
Measured: 15 weeks.
Anthropometric measurements of head circumference.
The change value from baseline at the end of the treatment.
Measured: 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.
Measured: 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.
Measured: 15 weeks.
Incidence of infectious diseases.
Observing the incidence of infectious diseases during the period of probiotic or placebo intervention.
Measured: 15 weeks.
Incidence of allergic diseases.
Observing the incidence of allergic diseases during the period of probiotic or placebo intervention.
Measured: 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.
Measured: 15 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start11 Feb 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hsieh-Hsun Ho
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Hsieh-Hsun Ho, Glac Biotech Co., Ltd
- Investigators
- Hsieh-Hsun Ho, Ph.D, Principal investigator, Glac Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140604
- Sponsor's protocol ID
- GLA-001
- Status last verified
- Jul 2023
- First submitted
- 22 Oct 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04140604
- Acronym / sponsor ID
- GLA-001
- Conditions
- Safety Issues
- Keywords
- Probiotic, Lactobacillus salivarius AP-32, Bifidobacterium animalis subsp. lactis CP-9, Safety, Healthy infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Hsieh-Hsun HoIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus salivarius AP-32 | Experimental | Other: Lactobacillus salivarius AP-32A 0.5 g light-yellow capsule containing freeze-dried powder of 2.5 billion CFU of Lactobacillus salivarius AP-32 and maltodextrin. |
| Bifidobacterium animalis subsp. lactis CP-9 | Experimental | Other: Bifidobacterium animalis subsp. lactis CP-9A 0.5 g light-yellow capsule containing freeze-dried powder of 2.5 billion CFU of Bifidobacterium animalis subsp. lactis CP-9 and maltodextrin. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo composition and appearance are the same as probiotic capsules, but does not contain live bacteria. |
Who may qualify
- Ages
- 7 to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus salivarius AP-32Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks. | Other | Lactobacillus salivarius AP-32 |
| Bifidobacterium animalis subsp. lactis CP-9Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks. | Other | Bifidobacterium animalis subsp. lactis CP-9 |
| PlaceboInfants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks. | Other | Placebo |
Primary outcome
Mean weight gain.
Time frame: 15 weeks.
The change value from baseline at the end of the treatment.
8 secondary outcomes
Occurrence of adverse events (AEs).
Time frame: 15 weeks.
Anthropometric measurements of recumbent length.
Time frame: 15 weeks.
Anthropometric measurements of head circumference.
Time frame: 15 weeks.
Incidence of regurgitation.
Time frame: 15 weeks.
Incidence of flatulence.
Time frame: 15 weeks.
Incidence of infectious diseases.
Time frame: 15 weeks.
Incidence of allergic diseases.
Time frame: 15 weeks.
Crying and/or fussing time (hours/day) and episodes.
Time frame: 15 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsieh-Hsun Ho, Ph.D principal investigator
Glac Biotech Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 in people with Safety Issues, run by Hsieh-Hsun Ho at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean weight gain. (time frame: 15 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.