Dietary Supplement With and Without a Probiotic and/or Antibiotic

February 13, 2025 updated by: Prolacta Bioscience

Dietary Study of a Complex Oligosaccharide With and Without a Probiotic Following Antibiotic Treatment 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

Intervention / Treatment

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 who have received antibiotics. The combination should support general gastrointestinal health.

This study is a multi-dose randomized cohort trial using 18 subjects per cohort for a total of 90 healthy adult volunteers ages 18-75.

Study Type

Observational

Enrollment (Actual)

92

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
        • Altasciences

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy Adults, ages 18-75.

Description

Inclusion Criteria:

  • Healthy adults between the ages of 18-75 years (subjects must be 18-75 at the time of consent) who can provide proof of vaccination against SARS-CoV-2. Proof may be a physical or electronic record of vaccination or self-attestation (to include approximate vaccination date and manufacturer of vaccine) if a copy of the vaccination record is not available
  • Subjects must have a BMI of 18 - 30 at screening visit
  • Willingness to complete study specific questionnaires
  • Willingness to complete journal to record IP dosing times, Bristol stool scores, and IP flavor questionnaires
  • Willingness to complete all study procedures, clinic visits, and provide required biospecimen samples
  • Willingness to collect and process stool samples at home and transport stool samples to clinic
  • Sexually active females of child-bearing potential must agree to use highly effective methods of contraception during heterosexual intercourse throughout the study period and for three days following discontinuation of IP, whichever comes later. Examples of highly effective methods include the use of two forms of contraception with one being an effective barrier method (e.g., a condom and spermicide used together), or have a vasectomised partner. Abstinence is acceptable as a life-style choice. Female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing
  • Provide informed consent

Exclusion Criteria:

  • Subjects with a BMI of 17 or less or 31 or greater are excluded
  • Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study
  • Subjects who intend to take a probiotic during the study
  • Subjects with self-reported diarrhea on day 1 prior to dosing, whereby diarrhea is defined as two or more episodes of watery and/or unformed stool within 24 hours
  • Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening and day 1 of the study
  • Unstable medical condition, in the opinion of the investigator
  • Subject with a history of allergy to the study antibiotics
  • Clinically significant abnormal laboratory test results at screening
  • Subjects who are unable or unwilling to provide stool samples on a regular basis as per study protocol
  • 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
  • Known carriers of C. difficile prior to study start, as determined by qPCR of stool
  • Known carriers of vancomycin-resistant enterococci (VRE) prior to study start, as determined by stool culture
  • Subjects with history of lactose intolerance

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1
D1-D5: Antibiotics (3x daily)
Dietary supplement: Antibiotic
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Arm 2
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily)
Dietary supplement: Antibiotic
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Dietary supplement: HMO Concentrate
Concentrated milk fortifiers from donor human milk
Dietary supplement: Probiotic
B. infantis
Arm 3
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic
Dietary supplement: Antibiotic
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Dietary supplement: Probiotic
B. infantis
Arm 4
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily)
Dietary supplement: Antibiotic
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Dietary supplement: HMO Concentrate
Concentrated milk fortifiers from donor human milk
Dietary supplement: Probiotic
B. infantis
Dietary supplement: Food Supplement
Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)
Arm 5
D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily)
Dietary supplement: Antibiotic
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Dietary supplement: Probiotic
B. infantis
Dietary supplement: Food Supplement
Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Time Frame: Baseline, Day, 5, 14, 35
Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.
Baseline, Day, 5, 14, 35

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Immune Markers Assessment at Day 5, 14 and 28
Time Frame: Baseline-28 days
Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.
Baseline-28 days
Blood Pressures of Subjects From Baseline to Day 35
Time Frame: Day 0 - 35
Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure [BP]). Descriptive statistics performed by dose group and visit.
Day 0 - 35
Heart Rates of Subjects From Baseline to Day 35
Time Frame: Day 0-35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.
Day 0-35
Respiratory Rates of Subjects From Baseline to Day 35
Time Frame: Day 0-35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.
Day 0-35
Temperatures of Subjects From Baseline to Day 35
Time Frame: Day 0-35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).
Day 0-35

Collaborators and Investigators

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

Sponsor

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)

September 21, 2021

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

June 9, 2022

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-CT-003

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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