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

NCT01886755 | Completed DMC

• 1 other identifier: CSUB0069
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Gastroenteritis

Keywords

Acute gastroenteritis; Probiotics; Lactobacillus reuteri; Zinc supplementation; Infants; Age 6 months to 36 months

Outcome Measures

Primary Outcomes (1)

• Resolution of diarrhoea.

  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 Outcomes (1)

• Reduction of severity of diarrhoea

  120 hrs from the start on treatment

Study Arms (2)

ORS with probiotic and zinc

EXPERIMENTAL

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

Interventions

ORS rehydration solution DIETARY_SUPPLEMENT

ORS with probiotic and zinc

placebo DIETARY_SUPPLEMENT

Placebo Comparator

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• months old children
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra Papadopoulou: lead
• BioGaia AB: collaborator

Study Sites (1)

Athens Children's Hospital "AGIA SOPHIA"

Athens, Attica, 11527, Greece

Location

MeSH Terms

Interventions

World Health Organization oral rehydration solution

Study Officials

• Alexandra Papadopoulou, Dr

  Athens Children's Hospital "AGIA SOPHIA"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Pediatrician

Study Record Dates

• First Submitted: June 22, 2013
• First Posted: June 26, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

GR (1)