Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis
Dietary Supplement: ORS rehydration solution
Dietary Supplement: placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Resolution of diarrhoea. [ Time Frame: 48 hrs after start of treatment ] [ Designated as safety issue: No ]
- 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
- Time from start of treatment and until last watery or soft stool.
- 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 :
- 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.
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.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01886755
|Contact: Alexandra Papadopoulou, Drfirstname.lastname@example.org|
|Athens Children's Hospital "AGIA SOPHIA"||Recruiting|
|Athens, Attica, Greece, 11527|
|Contact: Alexandra Papadopoulou, Dr 30 6945 29 30 71 email@example.com|
|Sub-Investigator: Panagiota Tsiligianni|
|Sub-Investigator: Maria Maragkoudaki, Dr|
|Sub-Investigator: Antonia Moutafi, Dr|
|Sub-Investigator: Ada Orfanakou, Dr|
|Sub-Investigator: Nasos Thomas, Dr|
|Sub-Investigator: George Houliaras, Dr|
|Sub-Investigator: Katerina Kapralou, Dr|
|Sub-Investigator: Garyfalia Hioti, Dr|
|Principal Investigator:||Alexandra Papadopoulou, Dr||Athens Children's Hospital "AGIA SOPHIA"|