BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Primary Purpose
Recurrent Clostridium Difficile Infection
Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus acidophilus CL1285® and Lactobacillus casei
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Clostridium Difficile Infection focused on measuring Clostridium difficile, diarrhea
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
- Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- Understand the nature and purpose of the study including potential risks and side effects
- Willing to comply with the requirements of the study
Exclusion Criteria:
- History of 2 or more clostridium difficile infections at any time prior to the current episode
- Presence of severe chronic and/or inflammatory condition
- Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
- Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- Use of proton pump inhibitors
- Pregnant female or breastfeeding
- Eating disorder
- History of alcohol, drug, or medication abuse
- Daily consumption of probiotics, fermented milk, and/or yogurt
- Known allergies to any substance in the study product
- Participation in another study with any investigational product within 3 months of screening
Sites / Locations
- Parker Jewish Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotic
Placebo
Arm Description
BIO-K+ CL1285
Placebo
Outcomes
Primary Outcome Measures
Incidence of recurrent Clostridium difficile infection
Secondary Outcome Measures
Duration of recurrent diarrhea episodes
Presence of gastrointestinal symptoms
Adverse events
Full Information
NCT ID
NCT01202630
First Posted
September 14, 2010
Last Updated
January 14, 2016
Sponsor
Bio-K Plus International Inc.
Collaborators
Sprim Advanced Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01202630
Brief Title
BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Official Title
A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Suspended
Why Stopped
The site is unable to recruit patients.
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio-K Plus International Inc.
Collaborators
Sprim Advanced Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Clostridium Difficile Infection
Keywords
Clostridium difficile, diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
BIO-K+ CL1285
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus acidophilus CL1285® and Lactobacillus casei
Other Intervention Name(s)
BIO-K+ CL 1285
Intervention Description
2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2 capsules of placebo (no live cells), consumed once daily for 60 days
Primary Outcome Measure Information:
Title
Incidence of recurrent Clostridium difficile infection
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Duration of recurrent diarrhea episodes
Time Frame
60 days
Title
Presence of gastrointestinal symptoms
Time Frame
60 days
Title
Adverse events
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
Understand the nature and purpose of the study including potential risks and side effects
Willing to comply with the requirements of the study
Exclusion Criteria:
History of 2 or more clostridium difficile infections at any time prior to the current episode
Presence of severe chronic and/or inflammatory condition
Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
Major gastrointestinal complication, e.g. Crohn's disease or ulcer
Current treatment with nasogastric tube, ostomy, or parenteral nutrition
Use of proton pump inhibitors
Pregnant female or breastfeeding
Eating disorder
History of alcohol, drug, or medication abuse
Daily consumption of probiotics, fermented milk, and/or yogurt
Known allergies to any substance in the study product
Participation in another study with any investigational product within 3 months of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelius J Foley, MD
Organizational Affiliation
Parker Jewish for Health Care and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parker Jewish Institute
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20145608
Citation
Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9.
Results Reference
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BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
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