Dietary Supplement With and Without a Probiotic

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    WCCT Global
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Updated on 19 February 2024
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Summary

Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.

Description

The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastrointestinal health.

The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-75.

Details
Condition Healthy Adult Subjects
Age 18years - 75years
Treatment Probiotic, Complex oligosaccharide, PPI
Clinical Study IdentifierNCT04433208
SponsorWCCT Global
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Healthy adults between the ages of 18-75 years
Willingness to complete all study procedures and clinic visits, and provide required samples
Provides informed consent

Exclusion Criteria

Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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