Imunoglukan PH4 syrup (10 mg of pleuran and 10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day.

A vitamin C syrup (10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight.

Diarrhoea;Acute

Children allocated to experimental group will receive Imunoglukan PH4 syrup (10 mg of pleuran and 10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day in the morning, before the first meal, until signs of AGE subside (< 3 stools / 24 hours and normalization of stool consistency - grade 2-5 according to Bristol Stool Form Scale) or until the 14th day of the intervention.

Imunoglukan PH4

Children allocated to control group will receive a placebo: a vitamin C syrup (10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day in the morning, before the first meal, until signs of AGE subside (< 3 stools / 24 hours and normalization of stool consistency - grade 2-5 according to Bristol Stool Form Scale) or until the 14th day of the intervention.

Placebo (vitamin C syrup)

The Department of Pediatrics with Clinical Assessment Unit, The Medical University of Warsaw

The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children

The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children- a Randomized, Placebo-controlled, Double-blind Trial

The duration of diarrhoea, defined as the time (hours) until normalization of stool consistency (grade 2, 3, 4 or 5 according to Bristol Stool Form Scale) and until normalization of number of stools per day.

The length of hospital stay due to AGE (number of days).

The need for intravenous rehydration will be assessed daily by physician, based on CDC (Centers for Disease Control and Prevention) and WHO dehydration scales.

Assessed on the basis of the diary completed by the physician and the caregiver.

Assessed by the Modified Vesikari Scale in the end of observation.

The Study protocol will be publicly available during the Study commencement. Other documents (Statistical Analysis Plan, Clinical Research Form, Informed Consent Form) will be available on request from authorized institutions.
Individual deidentified participant data will be available upon reasonable request for researchers who provide a methodologically sound proposal that has been approved by an independent bioethical committee. This will be available immediately after study result publication, for a minimum of 5 years. To gain access, data requestors will need to sign a data access agreement.
Additionally, The Medical University of Warsaw committed to share with PLEURAN s.r.o. an unprocessed, deidentified participant data obtained during the Study.

Medical University of Warsaw

Nutricia Foundation

PLEURAN s.r.o.

This will be a randomized, double-blind, placebo-controlled trial, with allocation 1:1.

All patients, their caregivers, researchers, physicians, nurses, the statistician will be blinded to the intervention.

glucan/փսխում

The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children

Բժշկական դեղաբույսերի ամենալավ տվյալների շտեմարանը, որին աջակցում է գիտությունը