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Completed

NCT Number: NCT04433208

Dietary Supplement With and Without a Probiotic

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.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WCCT Global

Cypress, California, 90630, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complex oligosaccharide

Dietary Supplement

Complex oligosaccharide concentrate

Probiotic

Dietary Supplement

Probiotic

PPI

Other

Over-the-counter proton pump inhibitor (PPI)

H2 Blocker

Other

Over-the-counter H2 blocker

Primary outcomes

  1. Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit

    Time frame: 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).

  3. Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prolacta Bioscience

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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