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Safety, Tolerability and Host Response to Lactobacillus Johnsonii

NCT02349360 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-06-14

Study results available
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Summary

The purpose of this research study is to determine the effects of the probiotic, Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria and blood biomarkers in healthy individuals.

Conditions

  • Healthy

Interventions

BIOLOGICAL

L. johnsonii N6.2

L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks

BIOLOGICAL

Placebo

Encapsulated starch placebo administered for 8 weeks

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Wendy J Dahl, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02349360 on ClinicalTrials.gov