Dietary Supplement With and Without a Probiotic

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

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.

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 18-44.

Inclusion Criteria:

• Healthy adults between the ages of 18-44 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