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

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

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01202630

Enrollment

140

Registered

2010-09-16

Start date

2010-06-30

Completion date

2016-01-31

Last updated

2016-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Clostridium Difficile Infection

Keywords

Clostridium difficile, diarrhea

Brief summary

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

Interventions

DIETARY_SUPPLEMENTLactobacillus 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_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of recurrent Clostridium difficile infection	60 days

Secondary

Measure	Time frame
Duration of recurrent diarrhea episodes	60 days
Presence of gastrointestinal symptoms	60 days
Adverse events	60 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026