Trial Outcomes & Findings for Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients (NCT NCT00328263)

Results Overview

Presence of at least one diarrhea episode within 24 hours.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

472 participants

Primary outcome timeframe

Up to 40 days

Results posted on

2014-08-07

Participant Flow

2151 patients were screened for eligibility. 437 patients were randomized for the study between March 2006 and October 2006.

Inclusion \& exclusion criterias were used to randomized patients. Patients were followed for an additionnal 21 days after treatment ended.

Participant milestones

Participant milestones
Measure	Bio-K+ CL1285 98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.	Placebo 98g/day of placebo (devoid of microorganisms)
Overall Study STARTED	216	221
Overall Study COMPLETED	213	217
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bio-K+ CL1285 n=216 Participants 98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.	Placebo n=221 Participants 98g/day of placebo (devoid of microorganisms)	Total n=437 Participants Total of all reporting groups
Age, Continuous	59.5 years STANDARD_DEVIATION 18.1 • n=39 Participants	58.1 years STANDARD_DEVIATION 19.1 • n=41 Participants	58.8 years STANDARD_DEVIATION 18.6 • n=35 Participants
Sex: Female, Male Female	99 Participants n=39 Participants	114 Participants n=41 Participants	213 Participants n=35 Participants
Sex: Female, Male Male	117 Participants n=39 Participants	107 Participants n=41 Participants	224 Participants n=35 Participants
Region of Enrollment Canada	216 participants n=39 Participants	221 participants n=41 Participants	437 participants n=35 Participants

PRIMARY outcome

Timeframe: Up to 40 days

Presence of at least one diarrhea episode within 24 hours.

Outcome measures

Outcome measures
Measure	Bio-K+ CL1285 n=216 Participants 98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.	Placebo n=221 Participants 98g/day of placebo (devoid of microorganisms)
The Incidence of Antibiotic-associated Diarrhea.	216 participants	221 participants

SECONDARY outcome

Timeframe: Up to 40 days

Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 40 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 40 days

Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1

Outcome measures

Outcome data not reported

Adverse Events

Bio-K+ CL1285

Serious events: 15 serious events

Other events: 109 other events

Deaths: 0 deaths

Placebo

Serious events: 23 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bio-K+ CL1285 n=216 participants at risk 98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.	Placebo n=221 participants at risk 98g/day of placebo (devoid of microorganisms)
General disorders Serious Adverse Events	6.9% 15/216 • Number of events 72	10.4% 23/221 • Number of events 76

Other adverse events

Other adverse events
Measure	Bio-K+ CL1285 n=216 participants at risk 98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.	Placebo n=221 participants at risk 98g/day of placebo (devoid of microorganisms)
Gastrointestinal disorders Gastrointestinal adverse events	16.2% 35/216	13.6% 30/221
Nervous system disorders Other adverse events	34.3% 74/216	37.6% 83/221

Additional Information

Dr. Serge Carrière

Bio-K+ International Inc.

Phone: 450-978-2465

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any proposed publication or formal presentation of the data directly derived from the study shall be submitted to Bio-K+. Bio-K+ will have 15 business days to give comments to the Investigator.This review is no way intended to restrict publication of facts or opinions formulated by the Investigator through this research.
Publication restrictions are in place

Restriction type: OTHER