Safety of an Oral Probiotic in Healthy Adults

NCT04492631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-10-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of an oral probiotic in healthy individuals.

Conditions

  • Healthy Adults

Interventions

DIETARY_SUPPLEMENT

Streptococcus salivarius DB-B5

Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day.

OTHER

Placebo

Sachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks.

Sponsors & Collaborators

  • Dose Biosystems Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Casser, M.D. · TKL Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2020-09-21
Completion
2020-09-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492631 on ClinicalTrials.gov