NCT01596829

Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Antibiotic treatment disturbs the balance of the intestinal microbiota and predisposes to antibiotic associated diarrhea. Previous studies have shown that the risk of developing diarrhea during a course of antibiotics may be reduced by simultaneous consumption of probiotics. The aim of the present study is to assess the effect of a probiotic formula containing four strains on reducing the risk of antibiotic associated diarrhea.

Detailed description

The aim of the study is to assess the effect of a probiotic formula on reducing the risk of antibiotic-associated diarrhea (AAD). The study will be conducted as a two-arm, parallel groups, placebo-controlled, double-blind, randomized clinical trial, stratified by age, gender and number of days on antibiotics. The duration of patient participation in the study will be up to 7 weeks (up to 3 weeks supplementation, 4 weeks follow-up). The overall duration of the study is expected to be approximately 8 months. Adult males and females that are prescribed antibiotic therapy for minimum of 3 and a maximum of 14 days will be included in the study. The incidence of AAD will be evaluated as the primary end-point. The stool from patients presenting diarrhea will be tested for the presence of Clostridium difficile and if negative for C. difficile, also for the presence of other common pathogens causing diarrhea. The overall microbiota will be analyzed from fecal samples taken regularly during each phase of the study.

Conditions

• Antibiotic-associated Diarrhoea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks
DIETARY_SUPPLEMENT	Placebo	A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-05-11
• Last updated: 2016-01-22

Locations

1 site across 1 country: Finland