Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional

Summary: 
      An ORS with L. reuteri DSM 17938 and zinc is expected to reduce duration and severity of
      symptoms in infants and young children with acute gastroenteritis.
    

Detailed description: 
      Oral rehydration solution is recommended for treatment and prevention of dehydration due to
      acute gastroenteritis in infants and children (WHO/UNICEF, 2004; ESPGHAN / ESPID Guidelines,
      2008). Acute diarrhoea may lead to zinc depletion in infants, and zinc supplementation is
      recommended in infants and children with acute gastroenteritis living in developing
      countries. In developed countries however, the studies on the efficacy of zinc
      supplementation in children with acute gastroenteritis are few and conflicting.

      Selected strains of probiotics, including L. reuteri ATCC 55730, have been shown in several
      studies to reduce the duration and the severity of diarrhoea in children with acute
      gastroenteritis and the effect is greater if the probiotics are given within 60 hours from
      the onset of symptoms. Lactobacillus reuteri (L. reuteri) has been shown to reduce the
      duration and severity of acute gastroenteritis in children aged 6-36 months. In these studies
      L. reuteri was reported to have clinical effect on diarrhoea of both bacterial and viral
      (rotavirus) origin. Furthermore, L. reuteri strain DSM 17938 has recently been shown to
      reduce the duration of watery diarrhoea by 1.2 days among 6-36 mo old Italian children with
      acute gastroenteritis treated in hospital.

      The present study is a prospective, randomized, double blind, controlled study with parallel
      groups. The planned investigation is designed to compare the efficacy of an ORS with L.
      reuteri DSM 17938 and zinc to an ORS with similar osmolarity and content of salts but without
      L. reuteri DSM 17938 and zinc, on the duration and severity of acute gastroenteritis. 92
      children aged 6-36 months seen at private pediatric clinics and/or at the emergency clinics
      of the Athens Childrens Hospital "AGIA SOPHIA", and treated either as outpatients or as
      inpatients will be recruited until the final sample size is reached. Assuming a difference of
      30% between groups in the primary outcome of prevalence of diarrhoea on day 2, and estimating
      an attrition rate of approximately 15%, the final sample size will be 92 subjects, or 46
      subjects in each arm.

      Data collection points will be on day 7 at the outpatient clinic of the Division of Pediatric
      Gastroenterology & Nutrition of the First Department of Paediatrics, Athens University
      Hospital.
    

Intervention name(s): ORS rehydration solution; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute gastroenteritis; Probiotics; Lactobacillus reuteri; Zinc supplementation; Infants; Age 6 months to 36 months