Clinical Trial Results:
Randomized, placebo controlled, double-blind, parallel group, multicentric Phase IV study on the clinical efficacy of lactic acid bacteria in form of hard capsules (capsule contains not less than 2 x 109 CFU of liophilisated lactic acid bacteria Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12) in ration 1:1) as prevention of antibiotic associated acute diarrhea in adults.
Summary
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EudraCT number |
2009-010713-69 |
Trial protocol |
SI |
Global completion date |
28 Jan 2010
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
27 May 2016
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First version publication date |
27 May 2016
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Other versions |
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Summary report(s) |
Sinopsis Linex forte 2009_2010_CT LINPT01 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.