NCT00792844

Brief Summary

Main research Question: The investigators would like to find out if both the Bio-K (lactobacillus acidophilus and lactobacillus casei) drink and capsule are equally effective in the prevention of diarrhea associated with antibiotic use. Why is this research project important? About 25% of patients who use antibiotics may develop diarrhea as a side effect. Symptoms are mild and consist of watery diarrhea and abdominal pain. Some patients may develop a more severe form of diarrhea, called clostridium difficile-associated diarrhea. Clostridium difficile-associated diarrhea may lead to more serious consequences like inflammation of the large bowel and in some cases, death. There are some studies that suggest Bio-K drink, a probiotic preparation containing lactobacillus acidophilus and lactobacillus casei, decreases the risk of diarrhea from antibiotic use. As a result, St. Joseph's Healthcare has recently to use Bio-K routinely to try to reduce risk of patients developing diarrhea. No other Hamilton hospitals use Bio-K routinely as there is not strong evidence about the effectiveness of Bio-K for the prevention of diarrhea. This study will provide more information about Bio-K's effectiveness in the prevention of diarrhea associated with antibiotic use as both a capsule and a drink.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 18, 2008

Status Verified

November 1, 2008

Enrollment Period

3 months

First QC Date

November 17, 2008

Last Update Submit

November 17, 2008

Conditions

Antibiotic-Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Antibiotic-associated diarrhea

    30 days after termination of antibiotic

Study Arms (3)

Bio-K capsule

EXPERIMENTAL

1 capsule of lactobacillus acidophilus and lactobacillus casei (50 billion live bacteria) daily for duration of antibiotic therapy and 7 days after or until discharge, whichever comes first

Dietary Supplement: Bio-K capsule formulation

Bio-K liquid

ACTIVE COMPARATOR

98 g of lactobacillus acidophilus and lactobacillus casei (50 billion live bacteria) daily for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever comes first

Dietary Supplement: Bio-K drink

no Bio-K

NO INTERVENTION

No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)

Interventions

Bio-K capsule formulationDIETARY_SUPPLEMENT

Bio-K 1 capsule formulation daily for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first

Bio-K capsule
Bio-K drinkDIETARY_SUPPLEMENT

Bio-K 98 g of diary-free soy beverage formulation for the duration of antibiotic treatment and for 7 days after termination of antibiotics or until hospital discharge, whichever occurs first

Bio-K liquid

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • speak English
  • capable of providing consent
  • reachable by telephone within the next three months
  • willing to comply with study protocols
  • age over 65 years
  • prescribed clindamycin, fluoroquinolones or cephalosporin for more than one dose

You may not qualify if:

  • ICU patients
  • transplant patients
  • patients on immunosuppressant medications (prednisone greater than 50 mg/day for 7 days, azathioprine, cyclosporine, cyclophosphamide, tacrolimus, sirolimus, methotrexate, mycophenolate, anti-TNF agents, interleukin-2 chemotherapy)
  • HIV patients with CD4+ count less than 250 cells/mm3
  • neutropenic patients with total neutrophil count less than 500
  • patients with prosthetic heart valves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton - Charlton Campus

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Central Study Contacts

Gloria Seto, BSchPhm

CONTACT

905-522-1155gseto@stjosham.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 18, 2008

Study Start

February 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 18, 2008

Record last verified: 2008-11

Locations

CA(1)