Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis

This study is currently recruiting participants.
Verified January 2014 by Aghia Sophia Children's Hospital of Athens
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Alexandra Papadopoulou, Aghia Sophia Children's Hospital of Athens
ClinicalTrials.gov Identifier:
NCT01886755
First received: June 22, 2013
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Acute Gastroenteritis
Dietary Supplement: ORS rehydration solution
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Aghia Sophia Children's Hospital of Athens:

Primary Outcome Measures:
  • Resolution of diarrhoea. [ Time Frame: 48 hrs after start of treatment ] [ Designated as safety issue: No ]
    1. Proportion of children without watery (3A ISS by Amsterdam infant stool scale ) or soft (3B ISS Amsterdam infant stool scale) stools on day 2 of treatment. Day 0 = day of enrolment and start of treatment, day 1 = first complete day of treatment
    2. Time from start of treatment and until last watery or soft stool.


Secondary Outcome Measures:
  • Reduction of severity of diarrhoea [ Time Frame: 120 hrs from the start on treatment ] [ Designated as safety issue: No ]

    Reduction of severity of diarrhoea will be evaluated as though :

    1. Number of watery (type 3A ISS ) and soft ( 3B ISS) stools daily on each of the day of the therapy and up to 5 days.
    2. Proportion of children with watery (3A ISS) and soft ( 3B ISS) stools on each of the day 1-5 (Day 0 = day of enrolment and start of treatment, day 1 = first complete day of treatment)

      • Νumber of vomiting episodes: per child on each of the treatment days 1-5.
      • Volume of ORS intake during the first 24h of treatment.
      • Need of hospitalization
      • Absence of workdays for the parents.
      • Child's absence from day care / nursery.
      • Medication needed for treatment of diarrhoea.


Estimated Enrollment: 92
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORS with probiotic and zinc
ORS with probiotic and zinc Oral rehydration solution with freeze-dried Lactobacillus reuteri DSM 17938 and zinc sulphate
Dietary Supplement: ORS rehydration solution
Placebo Comparator: Placebo Comparator
Standard oral rehydration solution
Dietary Supplement: placebo

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.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 - 36 months old children
  • 3 or more watery (3A ISS) or soft( 3B ISS ) stools per day for the past 24-48 hours
  • Clinically judged as having mild to moderate dehydration (Bailey scale scores 1 to 4)
  • Available throughout the study period
  • Re-examination on the 7th day from the enrolment
  • The signed informed consent by one/both parents or legal guardian
  • Parents or legal guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol

Exclusion Criteria:

  • Diarrhoea lasting more than 48 h
  • Clinical signs of severe dehydration (Bailey scale scores = or > 5)
  • Malnutrition as judged by a body weight/height ratio below the 5th percentile
  • Clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia)
  • Immunodeficiency
  • Severe chronic disease including cystic fibrosis
  • Food allergy diagnosed by physician or other chronic gastrointestinal diseases
  • Use of pre-/probiotics in the previous 2 weeks, for example infant formula containing probiotics and/or prebiotics.
  • Use of antibiotics or any anti-diarrhoeal medication in the previous 4 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886755

Contacts
Contact: Alexandra Papadopoulou, Dr 306945293071 papadop5@otenet.gr

Locations
Greece
Athens Children's Hospital "AGIA SOPHIA" Recruiting
Athens, Attica, Greece, 11527
Contact: Alexandra Papadopoulou, Dr    30 6945 29 30 71    papadop5@otenet.gr   
Sub-Investigator: Panagiota Tsiligianni         
Sub-Investigator: Smaragdi Fessatou, Dr         
Sub-Investigator: Antonia Moutafi, Dr         
Sub-Investigator: Ada Orfanakou, Dr         
Sub-Investigator: Nasos Thomas, Dr         
Sub-Investigator: George Houliaras, Dr         
Sponsors and Collaborators
Alexandra Papadopoulou
BioGaia AB
Investigators
Principal Investigator: Alexandra Papadopoulou, Dr Athens Children's Hospital "AGIA SOPHIA"
  More Information

No publications provided

Responsible Party: Alexandra Papadopoulou, Consultant Pediatrician, Aghia Sophia Children's Hospital of Athens
ClinicalTrials.gov Identifier: NCT01886755     History of Changes
Other Study ID Numbers: CSUB0069
Study First Received: June 22, 2013
Last Updated: January 5, 2014
Health Authority: Greece: Scientific Committee of the Athens Childrens Hospital "Agia Sophia"

Keywords provided by Aghia Sophia Children's Hospital of Athens:
Acute gastroenteritis
Probiotics
Lactobacillus reuteri
Zinc supplementation
Infants
Age 6 months to 36 months

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014