NCT01202630

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

5.6 years

First QC Date

September 14, 2010

Last Update Submit

January 14, 2016

Conditions

Recurrent Clostridium Difficile Infection

Keywords

Clostridium difficilediarrhea

Outcome Measures

Primary Outcomes (1)

  • Incidence of recurrent Clostridium difficile infection

    60 days

Secondary Outcomes (3)

  • Duration of recurrent diarrhea episodes

    60 days

  • Presence of gastrointestinal symptoms

    60 days

  • Adverse events

    60 days

Study Arms (2)

Probiotic

EXPERIMENTAL

BIO-K+ CL1285

Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Lactobacillus acidophilus CL1285® and Lactobacillus caseiDIETARY_SUPPLEMENT

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

Also known as: BIO-K+ CL 1285
Probiotic
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parker Jewish Institute

New Hyde Park, New York, 11040, United States

Location

Related Publications (1)

  • 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.

    PMID: 20145608BACKGROUND

MeSH Terms

Conditions

Clostridium InfectionsDiarrhea

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cornelius J Foley, MD

    Parker Jewish for Health Care and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 16, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

US(1)