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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Dietary supplement: Probiotic; Other: PPI; Dietary supplement: Complex oligosaccharide

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 18-75.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (PPI + 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.	Dietary supplement: Probiotic; Probiotic; Other: PPI; Over-the-counter proton pump inhibitor (PPI)
Experimental: Cohort 2 (Complex oligosaccharide + 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.	Other: PPI; Over-the-counter proton pump inhibitor (PPI); Dietary supplement: Complex oligosaccharide; Complex oligosaccharide concentrate
Experimental: Cohort 3-6 (Complex oligosaccharide + PPI +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	Dietary supplement: Probiotic; Probiotic; Dietary supplement: Complex oligosaccharide; Complex oligosaccharide concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Prolacta Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): December 2, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20-CT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No