NCT01667653

Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic capsule once daily
DIETARY_SUPPLEMENT	Placebo	Placebo capsule once daily

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-08-17
• Last updated: 2012-08-17

Locations

1 site across 1 country: Canada