Trial Outcomes & Findings for Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea (NCT NCT01058356)

Results Overview

AAD defined as: Watery stools more than 3 times per day for at least 2 days.

Recruitment status

COMPLETED

Target enrollment

214 participants

Primary outcome timeframe

Up to 14 days

Results posted on

2010-04-20

From September 2008 to November 2009, medical clinic

Patients who begin receiving antibiotics prior to 48 hours before enrollment in this study

Participant milestones
Measure	Lacidofil Capsule Versus Placebo Drug Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days)
Overall Study STARTED	214
Overall Study COMPLETED	172
Overall Study NOT COMPLETED	42

Reasons for withdrawal
Measure	Lacidofil Capsule Versus Placebo Drug Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days)
Overall Study Adverse Event	5
Overall Study Administration of contraindicated drugs	12
Overall Study Withdrawal by Subject	21
Overall Study Lost to Follow-up	4

Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea

Baseline characteristics by cohort
Measure	Lacidofil Capsule Versus Placebo Drug n=214 Participants Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days)
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	112 Participants n=39 Participants
Age, Categorical >=65 years	102 Participants n=39 Participants
Age Continuous	60.5 years STANDARD_DEVIATION 15.5 • n=39 Participants
Sex: Female, Male Female	82 Participants n=39 Participants
Sex: Female, Male Male	132 Participants n=39 Participants
Region of Enrollment Korea, Republic of	214 participants n=39 Participants

Timeframe: Up to 14 days

AAD defined as: Watery stools more than 3 times per day for at least 2 days.

Outcome measures
Measure	Lacidofil Capsule Versus Placebo Drug n=214 Participants Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days)
Presence of AAD	12 participants

Timeframe: Up to14 days

Outcome measures
Measure	Lacidofil Capsule Versus Placebo Drug n=214 Participants Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days)
Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)	25 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Pharmbio Korea Co., Ltd.

Phone: 82-2-587-2551