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BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

NCT01202630 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2016-01-15

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.

Conditions

  • Recurrent Clostridium Difficile Infection

Interventions

DIETARY_SUPPLEMENT

Lactobacillus acidophilus CL1285® and Lactobacillus casei

2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days

DIETARY_SUPPLEMENT

Placebo

2 capsules of placebo (no live cells), consumed once daily for 60 days

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    collaborator OTHER

  • Bio-K Plus International Inc.

    lead INDUSTRY

Principal Investigators

  • Cornelius J Foley, MD · Parker Jewish for Health Care and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

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 NCT01202630 on ClinicalTrials.gov