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

NCT01596829 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2016-01-22

No results posted yet for this study

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.

Conditions

  • Antibiotic-associated Diarrhoea

Interventions

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

Sponsors & Collaborators

  • Danisco

    lead INDUSTRY

Principal Investigators

  • Toivo Piippo, MD · Koskiklinikka Tampereen Lääkärikeskus Oy

  • Anneli Tarpila, PhD · Danisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Finland

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 NCT01596829 on ClinicalTrials.gov