Status:
COMPLETED
Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis
Lead Sponsor:
Alexandra Papadopoulou
Collaborating Sponsors:
BioGaia AB
Conditions:
Acute Gastroenteritis
Eligibility:
All Genders
6-36 years
Phase:
NA
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.
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 di...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01886755
Start Date
July 1 2013
End Date
December 1 2015
Last Update
February 23 2016
Active Locations (1)
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1
Athens Children's Hospital "AGIA SOPHIA"
Athens, Attica, Greece, 11527