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Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children

NCT02989350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-30

No results posted yet for this study

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.

Conditions

  • Acute Gastroenteritis

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938

Lactobacillus reuteri DSM 17938 vs Placebo

DIETARY_SUPPLEMENT

Placebo

Lactobacillus reuteri DSM 17938 vs Placebo

Sponsors & Collaborators

  • Szpital im. Św. Jadwigi Śląskiej

    lead OTHER

Principal Investigators

  • Henryk Szymański, MD PhD · Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02989350 on ClinicalTrials.gov