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

This study has been completed.
Sponsor:
Information provided by:
Pharmbio Korea Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01058356
First received: January 26, 2010
Last updated: April 15, 2010
Last verified: April 2010
History of Changes
Results First Received: March 8, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Antibiotics Associated Colitis
Pulmonary Infection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From September 2008 to November 2009, medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who begin receiving antibiotics prior to 48 hours before enrollment in this study

Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    Lacidofil Capsule Versus Placebo Drug  
STARTED     214  
COMPLETED     172  
NOT COMPLETED     42  
Adverse Event                 5  
Administration of contraindicated drugs                 12  
Withdrawal by Subject                 21  
Lost to Follow-up                 4  



  Baseline Characteristics
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Reporting Groups
  Description
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)

Baseline Measures
    Lacidofil Capsule Versus Placebo Drug  
Number of Participants  
[units: participants]
 		  214  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     112  
>=65 years     102  
Age  
[units: years]
Mean ± Standard Deviation 		  60.5  ± 15.5  
Gender  
[units: participants]
 		 
Female     82  
Male     132  
Region of Enrollment  
[units: participants]
 		 
Korea, Republic of     214  



  Outcome Measures
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1.  Primary:   Presence of AAD   [ Time Frame: Up to 14 days ]
  Show Outcome Measure 1

2.  Secondary:   Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)   [ Time Frame: Up to14 days ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Korea Association for the Study of Intestinal Disease (KASID)
Organization: Pharmbio Korea Co., Ltd.
phone: 82-2-587-2551
e-mail: pharmbio@hotmail.com


No publications provided


Responsible Party: NAM, Bong kil/ CEO & President, Pharmbio Korea
ClinicalTrials.gov Identifier: NCT01058356     History of Changes
Other Study ID Numbers: KASID_lacidofil_1
Study First Received: January 26, 2010
Results First Received: March 8, 2010
Last Updated: April 15, 2010
Health Authority: Korea: Institutional Review Board