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Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

NCT01667653 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-08-17

No results posted yet for this study

Summary

This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.

Conditions

  • Antibiotic Therapy

Interventions

DIETARY_SUPPLEMENT

Probiotic

Probiotic capsule once daily

DIETARY_SUPPLEMENT

Placebo

Placebo capsule once daily

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Danisco

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Canada

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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 NCT01667653 on ClinicalTrials.gov