Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT03988257
Description:
The Study protocol will be publicly available during the Study commencement. Other documents (Statistical Analysis Plan, Clinical Research Form, Informed Consent Form) will be available on request from authorized institutions.
Individual deidentified participant data will be available upon reasonable request for researchers who provide a methodologically sound proposal that has been approved by an independent bioethical committee. This will be available immediately after study result publication, for a minimum of 5 years. To gain access, data requestors will need to sign a data access agreement.
Additionally, The Medical University of Warsaw committed to share with PLEURAN s.r.o. an unprocessed, deidentified participant data obtained during the Study.
Study:
NCT03988257
Study Brief:
The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children