Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children (PROBAGE)
|ClinicalTrials.gov Identifier: NCT01927094|
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : February 2, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Diarrhea||Dietary Supplement: Probiotic Dietary Supplement: ORS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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: Prospective, Double Blind, Randomized Controlled Trial|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Active Comparator: Probiotic
Saccharomyces boulardii 1 x 250 mg per day for 5 days, PO or Lactobacillus GG 1 x 10(9) CFU per day for 5 days or
Lactobacillus reuteri 1 x 10(8) CFU per day for 5 days
Dietary Supplement: ORS
ORS ad libitum
Active Comparator: Control
Dietary Supplement: Probiotic
Comparison of probiotics vs. ORS
- Duration of diarrhea [ Time Frame: Day 7 ]Duration of diarrhea, since the beginning of the intervention, evaluated with Bristol scoring scale
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927094
|Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases|
|Sisli Etfal Training and Research Hospital,|
|Istanbul,, Turkey, 34000|
|Umraniye Education & Research Hospital, Department of Pediatrics|
|Principal Investigator:||Ener C Dinleyici, MD||Eskisehir Osmangazi University|