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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014