Study Results
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View full resultsBasic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2020-03-13
2020-12-02
Brief Summary
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Detailed Description
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The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-44.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1 (Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily
Probiotic
Probiotic
Cohort 2 (Complex oligosaccharide)
Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide
Complex oligosaccharide concentrate
Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide
Complex oligosaccharide concentrate
Probiotic
Probiotic
Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 9 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide
Complex oligosaccharide concentrate
Probiotic
Probiotic
Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker)
First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course
Complex oligosaccharide
Complex oligosaccharide concentrate
Probiotic
Probiotic
PPI
Over-the-counter proton pump inhibitor (PPI)
H2 Blocker
Over-the-counter H2 blocker
Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic)
Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Complex oligosaccharide
Complex oligosaccharide concentrate
Probiotic
Probiotic
Interventions
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Complex oligosaccharide
Complex oligosaccharide concentrate
Probiotic
Probiotic
PPI
Over-the-counter proton pump inhibitor (PPI)
H2 Blocker
Over-the-counter H2 blocker
Eligibility Criteria
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Inclusion Criteria
* Willingness to complete all study procedures and clinic visits, and provide required samples
* Provides informed consent
Exclusion Criteria
* Subjects with history of lactose intolerance
* Subjects who are on a PPI regimen
* Subjects who have taken a probiotic during the previous 30 days, or intends to take a probiotic during the study.
* Subjects who have taken antibiotics within 120 days
* Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening
* Unstable medical condition, in the opinion of the investigator
* Clinically significant abnormal laboratory test results at screening
* Participation in a clinical research trial within 30 days prior to screening
* Unable to give informed consent
* Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject
18 Years
44 Years
ALL
Yes
Sponsors
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Prolacta Bioscience
INDUSTRY
Responsible Party
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Locations
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WCCT Global
Cypress, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-CT-001
Identifier Type: -
Identifier Source: org_study_id
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