Clinical trial NCT01927094: Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Diarrhea
Keywords: probiotics, diarrhea
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2013-08-22
Enrollment: 1280
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* children of both sexes aged between 3 and 60 months, with acute watery diarrhea lasting more than 12 hours but less than 72 hours, requiring hospitalization. Children with clinical signs of mild to moderate dehydration (prolonged capillary refill time, abnormal skin turgor and 3-9% percentage loss of body weight).

Exclusion Criteria:

* clinical features of hypovolemic shock and/or necessitating admission at the intensive care unit were excluded. Other exclusion criteria were use of antibiotics or probiotics 1 month before admission, severe malnutrition and chronic underlying disease including immunocompromised conditions

Primary outcomes:
measure: Duration of diarrhea
timeFrame: Day 7
Secondary outcomes:
measure: Percentage of children with diarrhea at the 3rd day of intervention
timeFrame: Day 3
measure: Duration of hospitalization
timeFrame: Day 5
measure: Safety of probiotics
timeFrame: 5 days of intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Sami Ulus Research and Training Hospital of Women's and Children's Health and Diseases
city: Istanbul,
country: Turkey
facility: Sisli Etfal Training and Research Hospital,
city: Istanbul
country: Turkey
facility: Umraniye Education & Research Hospital, Department of Pediatrics
Study officials:
affiliation: Eskisehir Osmangazi University
name: Ener C Dinleyici, MD
role: PRINCIPAL_INVESTIGATOR
References: