NCT01941160

Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment

A Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of a Probiotic Product, Lacidofil® STRONG, in Healthy Adults Taking Antibiotic Treatment

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: KGK Science Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID.

Detailed description

It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving Lacidofil® STRONG compared to those receiving placebo.

Conditions

• Antibiotic Associated Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lacidofil® STRONG	Lacidofil® STRONG capsule twice daily
DIETARY_SUPPLEMENT	Placebo	Placebo capsule twice daily

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-09-13
• Last updated: 2014-05-14

Locations

1 site across 1 country: Canada