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

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ClinicalTrials.gov Identifier: NCT01058356
Recruitment Status : Completed
First Posted : January 28, 2010
Results First Posted : March 31, 2010
Last Update Posted : April 20, 2010
Sponsor:
Information provided by:
Pharmbio Korea Co., Ltd.

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Conditions Antibiotics Associated Colitis
Pulmonary Infection
Enrollment 214
Recruitment Details From September 2008 to November 2009, medical clinic
Pre-assignment Details Patients who begin receiving antibiotics prior to 48 hours before enrollment in this study
Arm/Group Title Lacidofil Capsule Versus Placebo Drug
Hide Arm/Group Description

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)

Period Title: Overall Study
Started 214
Completed 172
Not Completed 42
Reason Not Completed
Adverse Event             5
Administration of contraindicated drugs             12
Withdrawal by Subject             21
Lost to Follow-up             4
Arm/Group Title Lacidofil Capsule Versus Placebo Drug
Hide Arm/Group Description

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 Number of Baseline Participants 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants
<=18 years
0
   0.0%
Between 18 and 65 years
112
  52.3%
>=65 years
102
  47.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants
60.5  (15.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants
Female
82
  38.3%
Male
132
  61.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 214 participants
214
1.Primary Outcome
Title Presence of AAD
Hide Description AAD defined as: Watery stools more than 3 times per day for at least 2 days.
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacidofil Capsule Versus Placebo Drug
Hide Arm/Group Description:

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 Number of Participants Analyzed 214
Measure Type: Number
Unit of Measure: participants
12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lacidofil Capsule Versus Placebo Drug
Comments

Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.

Power calculation:

The assumption of sample size calculation:

difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%

- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.17 to 4.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.40
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)
Hide Description [Not Specified]
Time Frame Up to14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacidofil Capsule Versus Placebo Drug
Hide Arm/Group Description:

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 Number of Participants Analyzed 214
Measure Type: Number
Unit of Measure: participants
25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lacidofil Capsule Versus Placebo Drug
Comments

Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.

Power calculation:

The assumption of sample size calculation:

difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%

- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.18 to 1.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacidofil Capsule Versus Placebo Drug
Hide Arm/Group Description

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)

All-Cause Mortality
Lacidofil Capsule Versus Placebo Drug
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lacidofil Capsule Versus Placebo Drug
Affected / at Risk (%)
Total   0/214 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.3%
Lacidofil Capsule Versus Placebo Drug
Affected / at Risk (%)
Total   0/214 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Korea Association for the Study of Intestinal Disease (KASID)
Organization: Pharmbio Korea Co., Ltd.
Phone: 82-2-587-2551
EMail: pharmbio@hotmail.com
Layout table for additonal information
Responsible Party: NAM, Bong kil/ CEO & President, Pharmbio Korea
ClinicalTrials.gov Identifier: NCT01058356     History of Changes
Other Study ID Numbers: KASID_lacidofil_1
First Submitted: January 26, 2010
First Posted: January 28, 2010
Results First Submitted: March 8, 2010
Results First Posted: March 31, 2010
Last Update Posted: April 20, 2010