Safety Study of Human Milk Oligosaccharides in Healthy Adults
NCT ID: NCT05516225
Last Updated: 2022-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2016-09-29
2017-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PBCLN-003, 1.8 g daily in 3 divided oral doses for 7 days
PBCLN-003
Human Milk Oligosaccharide Concentrate
PBCLN-003, 3.6 g daily in 3 divided oral doses for 7 days
PBCLN-003
Human Milk Oligosaccharide Concentrate
PBCLN-003, 9 g daily in 3 divided oral doses for 7 days
PBCLN-003
Human Milk Oligosaccharide Concentrate
PBCLN-003, 18 g daily in 3 divided oral doses for 7 days
PBCLN-003
Human Milk Oligosaccharide Concentrate
Interventions
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PBCLN-003
Human Milk Oligosaccharide Concentrate
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 50 years old
* No diagnosed medical conditions
* No significant change to diet in the 2 weeks prior to enrollment
* Agreement to use contraception for female subjects
Exclusion Criteria
* Pregnancy
* Lactation
* Enrollment in another clinical study
18 Years
50 Years
ALL
Yes
Sponsors
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Prolacta Bioscience
INDUSTRY
Responsible Party
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Locations
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WCCT Global, LLC
Cypress, California, United States
Countries
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References
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Jacobs JP, Lee ML, Rechtman DJ, Sun AK, Autran C, Niklas V. Human milk oligosaccharides modulate the intestinal microbiome of healthy adults. Sci Rep. 2023 Aug 31;13(1):14308. doi: 10.1038/s41598-023-41040-5.
Other Identifiers
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16-CLN-003
Identifier Type: -
Identifier Source: org_study_id
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