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Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults

NCT01568567 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-07-04

No results posted yet for this study

Summary

Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.

Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.

Conditions

  • Safety

Interventions

DIETARY_SUPPLEMENT

Lactobacillus Reuteri DSM 17938

One stick pack in the morning and one stick pack afternoon/evening for 28 days.

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Good Food Practice, Sweden

    lead INDUSTRY

Principal Investigators

  • Johan Olsson, PhD · KPL Good Food Practice AB

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
2012-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT01568567 on ClinicalTrials.gov