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; Other: H2 Blocker

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.

• 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)
• Accepts Healthy Volunteers: Yes

Description

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 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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (Probiotic); Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily	Dietary supplement: Probiotic; Probiotic
Experimental: Cohort 2 (Complex oligosaccharide); Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily	Dietary supplement: Complex oligosaccharide; Complex oligosaccharide concentrate
Experimental: Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic); Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily	Dietary supplement: Probiotic; Probiotic; Dietary supplement: Complex oligosaccharide; Complex oligosaccharide concentrate
Experimental: Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic); Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 9 g dose of complex oligosaccharide orally twice daily	Dietary supplement: Probiotic; Probiotic; Dietary supplement: Complex oligosaccharide; Complex oligosaccharide concentrate
Experimental: Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker); First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily *4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course	Dietary supplement: Probiotic; Probiotic; Other: PPI; Over-the-counter proton pump inhibitor (PPI); Dietary supplement: Complex oligosaccharide; Complex oligosaccharide concentrate; Other: H2 Blocker; Over-the-counter H2 blocker
Experimental: Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic); Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily	Dietary supplement: Probiotic; Probiotic; Dietary supplement: Complex oligosaccharide; Complex oligosaccharide concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR	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.	All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Concentration of Blood Parameters From Day 1 to Day 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.	Day 1 - 15
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit	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).	Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 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.	Day 1, 8, 15, 29
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)	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.	Day 1 - 15
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)	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.	Day 1 - 15

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Histamine H2 Antagonists
• 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