Clinical Trial Results:
Phase III, randomized, double blind, parallel groups, clinical trial to evaluate the efficacy and safety of Bacillus clausii versus placebo in the prevention of antibiotic associated diarrhea (AAD) in children
Summary
|
|
EudraCT number |
2020-000970-10 |
Trial protocol |
HU |
Global completion date |
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
10 Jul 2022
|
First version publication date |
10 Jul 2022
|
Other versions |
|
Summary report(s) |
LPS16140_results summary for terminated study |
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.