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

January 14, 2016 updated by: Bio-K Plus International Inc.

A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Parker Jewish Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
  3. Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
  4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
  5. Understand the nature and purpose of the study including potential risks and side effects
  6. Willing to comply with the requirements of the study

Exclusion Criteria:

  1. History of 2 or more clostridium difficile infections at any time prior to the current episode
  2. Presence of severe chronic and/or inflammatory condition
  3. Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
  4. Major gastrointestinal complication, e.g. Crohn's disease or ulcer
  5. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
  6. Use of proton pump inhibitors
  7. Pregnant female or breastfeeding
  8. Eating disorder
  9. History of alcohol, drug, or medication abuse
  10. Daily consumption of probiotics, fermented milk, and/or yogurt
  11. Known allergies to any substance in the study product
  12. Participation in another study with any investigational product within 3 months of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
2 capsules of placebo (no live cells), consumed once daily for 60 days
EXPERIMENTAL: Probiotic
BIO-K+ CL1285
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
Other Names:
  • BIO-K+ CL 1285

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of recurrent Clostridium difficile infection
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 60 days
60 days
Duration of recurrent diarrhea episodes
Time Frame: 60 days
60 days
Presence of gastrointestinal symptoms
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-K Plus International Inc.

Collaborators

Sprim Advanced Life Sciences

Investigators

  • Principal Investigator: Cornelius J Foley, MD, Parker Jewish for Health Care and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2016

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (ESTIMATE)

September 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-SUS-05-BIK-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Clostridium Difficile Infection

Clinical Trials on Lactobacillus acidophilus CL1285® and Lactobacillus casei

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe