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Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract.

NCT03143400 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-05-01

No results posted yet for this study

Summary

The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus salivarius, in the digestive tract of healthy volunteers and of ileostomized patients, depending on its galenic form.

Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.

Conditions

  • Healthy Volunteer
  • Terminal Ileostomy

Interventions

DRUG

Lactobacillus salivarius BL 3123

Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.

Sponsors & Collaborators

  • 3i nature

    collaborator OTHER

  • European Regional Development Fund

    collaborator OTHER

  • Université d'Auvergne

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • France

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 NCT03143400 on ClinicalTrials.gov