Comparison of Two Formulations of Bio-K

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00792844
First received: November 17, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Antibiotic-Associated Diarrhea
Dietary Supplement: Bio-K capsule formulation
Dietary Supplement: Bio-K drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Two Formulations of Lactobacillus Acidophilus and Lactobacillus Casei in the Prevention of Antibiotic-Associated Diarrhea: a Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Antibiotic-associated diarrhea [ Time Frame: 30 days after termination of antibiotic ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2009
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bio-K capsule
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 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
Active Comparator: Bio-K liquid
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
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
No Intervention: no Bio-K
No lactobacillus product - standard infection control procedures (i.e. handwashing, etc.)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792844

Contacts
Contact: Gloria Seto, BSchPhm 905-522-1155 ext 33803 gseto@stjosham.on.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton - Charlton Campus Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Gloria Seto       gseto@stjosham.on.ca   
Principal Investigator: Gloria Seto, BScPhm         
Sponsors and Collaborators
McMaster University
  More Information

No publications provided

Responsible Party: Gloria Seto, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT00792844     History of Changes
Other Study ID Numbers: 1-Seto
Study First Received: November 17, 2008
Last Updated: November 17, 2008
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 17, 2014