Study Evaluating the Safety and Tolerability of a Probioitc
NCT05044949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2022-02-11
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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