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Clinical Study to Evaluate the Safety and Efficacy of New Probiotic Strains in Health Adults

NCT04758845 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2021-02-17

No results posted yet for this study

Summary

This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.

Conditions

  • Gastrointestinal Health
  • Respiratory Health
  • Safety

Interventions

DIETARY_SUPPLEMENT

Cocktail

Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.

DIETARY_SUPPLEMENT

CGI314

Subjects will consume 1B CFU of CGI314 once daily for 45 days.

DIETARY_SUPPLEMENT

CSI08

Subjects will consume 1B CFU of CSI08 once daily for 45 days.

DIETARY_SUPPLEMENT

MIT411

Subjects will consume 1B CFU of MIT411 once daily for 45 days.

Sponsors & Collaborators

  • Deerland Enzymes

    lead INDUSTRY

Principal Investigators

  • Lilijana K Besednjak, MD PhD · Health Center Nova Gorica

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2021-04-30
Completion
2021-05-31

Countries

  • Slovenia

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 NCT04758845 on ClinicalTrials.gov