Dietary Supplement With and Without a Probiotic

NCT04433208 | Completed Results

• 1 other identifier: 20-CT-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in Concentration of Blood Parameters From Day 1 to Day 15

  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

  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

  Day 1, 8, 15, 29

• Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)

  Day 1 - 15

• Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)

  Day 1 - 15

Study Arms (6)

Cohort 1 (Probiotic)

EXPERIMENTAL

Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily

Dietary Supplement: Probiotic

Cohort 2 (Complex oligosaccharide)

EXPERIMENTAL

Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily

Dietary Supplement: Complex oligosaccharide

Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic)

EXPERIMENTAL

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: Complex oligosaccharide; Dietary Supplement: Probiotic

Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic)

EXPERIMENTAL

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: Complex oligosaccharide; Dietary Supplement: Probiotic

Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker)

EXPERIMENTAL

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: Complex oligosaccharide; Dietary Supplement: Probiotic; Other: PPI; Other: H2 Blocker

Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic)

EXPERIMENTAL

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: Complex oligosaccharide; Dietary Supplement: Probiotic

Interventions

Complex oligosaccharide DIETARY_SUPPLEMENT

Complex oligosaccharide concentrate

Cohort 2 (Complex oligosaccharide); Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic); Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic); Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker); Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic)

Probiotic DIETARY_SUPPLEMENT

Probiotic

Cohort 1 (Probiotic); Cohort 3 (4.5 g Dose of Complex oligosaccharide + Probiotic); Cohort 4 (9 g dose of Complex oligosaccharide + Probiotic); Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker); Cohort 6 (18 g dose of Complex oligosaccharide + Probiotic)

PPI OTHER

Over-the-counter proton pump inhibitor (PPI)

Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker)

H2 Blocker OTHER

Over-the-counter H2 blocker

Cohort 5 (18 g dose of Complex oligosaccharide + PPI + Probiotic +/- H2 Blocker)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prolacta Bioscience: lead

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

Probiotics; Histamine H2 Antagonists

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Results Point of Contact

• Title: Dr David Rechtman VP, Medical Affairs
• Organization: Prolacta Bioscience

drechtman@prolacta.com

8887765228

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 16, 2020
• Study Start: March 13, 2020
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)