Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea

NCT01972932 | Terminated Phase 4

• 1 other identifier: CHUM 2014-5056
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotic-associated diarrhea (AAD) and particularly Clostridium difficile-Infection (CDI) are the most common causes of healthcare associated infectious diarrhea. In light of the results obtained in a limited number of randomized clinical trials in subjects with AAD and CDI in comparison with the widespread occurrence of these diseases, it is felt that the addition of a well-controlled clinical trial in a western environment would add value to support the use of a specific probiotic to counteract these diseases.

Conditions

Clostridium Difficile Infection; Antibiotic Associated Diarrhea

Keywords

Bio-K+®; Placebo; AAD; CDI; hospitalized subjects

Outcome Measures

Primary Outcomes (1)

• To evaluate the incidence of Clostridium Difficile infection

  The primary objective of this study is evaluate the incidence risk ratio of CDI in hospitalized subjects treated with systemic antibiotics, taking oral administration of Bio-K+® in comparison with a placebo. Risk will be calculated for the period of antibiotic treatment plus 65 days.

  2 Years

Secondary Outcomes (1)

• To evaluate the incidence of antibiotic associated diarrhea

  2 Years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

Dietary Supplement: Placebo

Bio K+®

ACTIVE COMPARATOR

Bio K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic.

Dietary Supplement: Bio K+® 2 capsules orally (or via nasogastric tube)

Interventions

Bio K+® 2 capsules orally (or via nasogastric tube) DIETARY_SUPPLEMENT

Bio-K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic.

Also known as: Bio-K+®

Bio K+®

Placebo DIETARY_SUPPLEMENT

Placebo Comparator: 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years old
• Able to tolerate food intake Antibiotic treatment started less than 48hrs from admission into the study
• Have an expected hospitalization period of at least three days (including subject"s stay in the emergency room)
• Speak and understand English and/or French.
• Have an expected survival greater than 60 days
• Agree to refrain from taking probiotic products (besides the study drug) during the study period Have given informed consent In addition, women of child bearing capacity who are not pregnant at the moment of screening (pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. Condom, oral contraceptives, etc.) are allowed to participate.

You may not qualify if:

• Have been diagnosed with CDI in previous sixty days
• Are currently suffering from any health condition causing immunosuppression (including haematological malignancies, lymphoma, AIDS, transplant, and hemodialysis)
• Have received more than 10 mg of prednisone per day for at least 1 month within 3 months prior to the participation to the study.
• Have active diarrhea (three or more liquid stools per 24 hour period) or non-controlled intestinal disease/colitis such as Crohn's disease, ulcerative colitis or caeliac disease Have stomas, are ostomized or are parenteral nutrition users Have already been randomized to one arm of this study
• Are known to have shown a previous reaction, including anaphylaxis, to any substance in the composition of the study products (i.e. Non-medicinal ingredients: Cellulose, hypromellose, medium chain triglycerides, sodium alginate, ascorbic acid, magnesium stearate (vegetal source), silicon dioxide and titanium dioxide
• Where receiving systemic antibiotics on admission to the hospital or who have been treated with antibiotics over the past two weeks Have lactose intolerance or milk allergy
• Have difficulties giving informed consent because of chronic mental disease, dementia
• Are not likely to comply with study requirements (provide stool for screening if diarrhea or answer to the follow up questionnaires)
• Have been known to use illicit drugs in the last two years. Have participated in another clinical study in the last 30 days
• Female subjects that are pregnant, or who intend to become pregnant or are lactating during the study period
• Female subjects of child bearing potential not currently using adequate contraception

Sponsors & Collaborators

• Bio-K Plus International Inc.: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Mikhael Laskine, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

• Serge Carriere, MD

  Bio-K+International Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: August 1, 2017
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

CA (1)