Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-27 @ 1:54 AM
Study NCT ID:
NCT02989350
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children
Sponsor:
Szpital im. Św. Jadwigi Śląskiej
Organization:
Study Overview
Official Title:
Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Considering that evidence on L reuteri remains limited, the investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately.
Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: