Dietary Supplement With and Without a Probiotic

March 10, 2025 updated by: Prolacta Bioscience

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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).
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
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.
Day 1, 8, 15, 29
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.
Day 1 - 15
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.
Day 1 - 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prolacta Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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