NCT01927094

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

The Effect of a Probiotic and/or Prebiotic on the Duration of Diarrhea and Length of Hospital Stay in Children With Acute Diarrhea: Prospective, Double Blind, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,280 (actual)
• Sponsor: Eskisehir Osmangazi University · Academic / Other
• Sex: All
• Age: 3 Months – 60 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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. A recent Cochrane review including 56 trials in children concluded that specific probiotics reduce the duration of diarrhea with about 24 hours and decrease the frequency of defecation on the second day. Current evidence also indicates that probiotic effects are strain-specific. Lactobacillus LGG 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. The aim of this study was to evaluate effects of different probiotics on the duration of acute infectious diarrhea.

Conditions

• Acute Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Comparison of probiotics vs. ORS
DIETARY_SUPPLEMENT	ORS	ORS ad libitum

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-08-22
• Last updated: 2018-02-05

Locations

3 sites across 1 country: Turkey (Türkiye)