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

Paused · Phase 3 · Has a placebo group

Conditions studied: Recurrent Clostridium Difficile Infection

In brief

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

Key facts

Study ID

NCT01202630

Run by

Bio-K Plus International Inc.

People needed

140

Starts

2010-06-01

Expected to finish

2016-01-01

Last updated by the study team

2016-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.