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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effect of a Probiotic and/or Prebiotic on the Duration of Diarrhea and Length of Hospital Stay in Children With Acute Diarrhea: Prospectiv

Brief 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 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. 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.
Sponsor: Eskisehir Osmangazi University

Current Primary Outcome: Duration of diarrhea [ Time Frame: Day 7 ]

Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of children with diarrhea at the 3rd day of intervention [ Time Frame: Day 3 ]
    Percentage of children with diarrhea at the 3rd day of intervention
  • Duration of hospitalization [ Time Frame: Day 5 ]
    Lenght of stay of hoospitalization
  • Safety of probiotics [ Time Frame: 5 days of intervention ]
    All clinical conditions (related with probiotics) should be noted.


Original Secondary Outcome: Same as current

Information By: Eskisehir Osmangazi University

Dates:
Date Received: August 13, 2013
Date Started: June 2012
Date Completion:
Last Updated: February 12, 2015
Last Verified: February 2015