Dietary Supplement With and Without a Probiotic

Not Applicable

Completed

Conditions: Healthy Adult Subjects

Interventions: Dietary Supplement: Complex oligosaccharide
Dietary Supplement: Probiotic
Other: PPI

Registration Number: NCT04433208

Lead Sponsor: Prolacta Bioscience

Brief 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.

Detailed 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 18-44.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)	Probiotic	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
Cohort 2 (Complex oligosaccharide + PPI)	PPI	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.
Cohort 3-6 (Complex oligosaccharide + PPI +probiotic)	Complex oligosaccharide	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
Cohort 1 (PPI + probiotic)	PPI	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.
Cohort 2 (Complex oligosaccharide + PPI)	Complex oligosaccharide	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.
Cohort 1 (PPI + probiotic)	Probiotic	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR	All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57	qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species.

Secondary Outcome Measures

Name	Time	Method
Changes in Concentration of Blood Parameters From Day 1 to Day 15	Day 1 - 15	Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit	Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57	Evaluation of B. infantis levels in Dose Group 5 will be compared to B. infantis levels in Dose Groups 6 using descriptive statistics including geometric means and 95% confidence intervals of the genome copy number per nanogram of DNA (B. infantis copies/ng DNA).
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29	Day 1, 8, 15, 29	Descriptive statistics including means and standard deviation of lactate (Cohort 1; 0g HMO + B. infantis, Cohort 2; 18 g HMO, engrafted subjects and not engrafted subjects from Cohorts 5 \& 6 combined; 18g HMO + B. infantis). Descriptive statistics will not include analytes that were not detected in greater than 50% of samples.
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)	Day 1 - 15	Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)	Day 1 - 15	Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function and electrolytes and glucose.