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

February 20, 2016 updated by: Alexandra Papadopoulou
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11527
        • Athens Children's Hospital "AGIA SOPHIA"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6 - 36 months old children
  • 3 or more watery or soft 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of diarrhoea.
Time Frame: 48 hrs after start of treatment
  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.
48 hrs after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of severity of diarrhoea
Time Frame: 120 hrs from the start on treatment

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.
120 hrs from the start on treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandra Papadopoulou

Collaborators

BioGaia AB

Investigators

  • Principal Investigator: Alexandra Papadopoulou, Dr, Athens Children's Hospital "AGIA SOPHIA"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

June 22, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (ESTIMATE)

June 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 20, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSUB0069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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