Dietary Supplement With and Without a Probiotic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dietary Study of a Complex Oligosaccharide With and Without a Probiotic in Healthy Volunteers

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Dietary Supplement: Complex oligosaccharide
* Dietary Supplement: Probiotic
* Other: PPI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 (PPI + probiotic)<br>Subjects in Cohort 1 will take a PPI and a probiotic orally once daily on Days 1-7. Subjects will mix the probiotic in an aqueous diluent supplied by the pharmacy and ingest between 1-2 hours after taking a PPI. | Dietary Supplement: Probiotic<br>* Probiotic<br>Other: PPI<br>* Over-the-counter proton pump inhibitor (PPI)<br>|
| Experimental: Cohort 2 (Complex oligosaccharide + PPI)<br>Subjects in Cohort 2 will take the complex oligosaccharide orally twice daily on Days 1-14. On Days 1-7, the first dose of the complex oligosaccharide will be taken between 1-2 hours after taking a PPI. On Days 8-14, subjects will not take a PPI prior to the complex oligosaccharide. | Dietary Supplement: Complex oligosaccharide<br>* Complex oligosaccharide concentrate<br>Other: PPI<br>* Over-the-counter proton pump inhibitor (PPI)<br>|
| Experimental: Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)<br>Subjects in Cohort 3, 4, and 6 will take a complex oligosaccharide orally twice daily (doses will vary per cohort) on Days 1-14 in combination with a probiotic orally once daily on Days 1-7. Cohort 5 will undergo the same dosing regimen a second time on days 29-43 | Dietary Supplement: Complex oligosaccharide<br>* Complex oligosaccharide concentrate<br>Dietary Supplement: Probiotic<br>* Probiotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the changes in microbiome species abundance and diversity from baseline until end of study |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of blood parameters, such as cytokine levels | Blood samples will be collected for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose. | 30 days | 
| Percentage of participants requiring PPI for probiotic engraftment | Determination of the need for protection of the probiotic from stomach acid in order for engraftment of the organism into the gut microbiome to occur | 30 days | 
| Number and severity (mild, moderate, or severe) of adverse events and relationship to the study product. | Adverse events will be summarized by severity and relationship to the study drug | 30 days |