Study Evaluating the Safety and Tolerability of a Probioitc

NCT05044949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-02-11

No results posted yet for this study

Summary

The rationale for the current study is to initially evaluate the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in healthy volunteers.

Conditions

  • Healthy Volunteers
  • Tolerability
  • Safety

Interventions

OTHER

Probiotic

The study product is a probiotic strain

OTHER

Placebo

The study product is a placebo to the probiotic strain

Sponsors & Collaborators

  • BioGaia AB

    lead INDUSTRY

Principal Investigators

  • Erik Rein-Hedin, MD · CTC Clinical Trial Consultants AB,Dag Hammarskjolds v- 10B, SE-752 37 Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2021-12-31
Completion
2022-01-20

Countries

  • Sweden

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 NCT05044949 on ClinicalTrials.gov