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Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children

NCT01927094 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2018-02-05

No results posted yet for this study

Summary

* Acute diarrhea continues to be a major cause of childhood morbidity and mortality in developed and developing countries.
* Prevention and treatment of dehydration are the mainstays of therapy. Rehydration can be achieved with oral rehydratation solution (ORS).
* Even though ORS has reduced the mortality and morbidity very significantly, it has no effect on the duration of diarrhea, stool consistency and frequency and remains underused.
* ESPGHAN and ESPID published together an evidence based guideline and stated that in the management of acute gastroenteritis rehydration is the key treatment and that selected probiotics may reduce the duration and intensity of symptoms and can be used as an adjuvant to ORS.
* Current evidence also indicates that probiotic effects are strain-specific. Lactobacillus GG and Saccharomyces boulardii are the best studied strains. However, more research is needed to guide the use of particular probiotic regimens and strains and as there is still no evidence of efficacy for many preparations.

Conditions

  • Acute Diarrhea

Interventions

DIETARY_SUPPLEMENT

Probiotic

Comparison of probiotics vs. ORS

DIETARY_SUPPLEMENT

ORS

ORS ad libitum

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    lead OTHER

Principal Investigators

  • Ener C Dinleyici, MD · Eskisehir Osmangazi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Turkey (Türkiye)

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 NCT01927094 on ClinicalTrials.gov