The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children

PHASE4CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

June 24, 2019

Primary Completion Date

September 1, 2022

Study Completion Date

December 31, 2022

Conditions
Diarrhoea;Acute
Interventions
DIETARY_SUPPLEMENT

Imunoglukan PH4

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.

DIETARY_SUPPLEMENT

Placebo (vitamin C syrup)

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.

Trial Locations (1)

02-091

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Nutricia Foundation

OTHER

collaborator

Pleuran, s.r.o.

INDUSTRY

lead

Medical University of Warsaw

OTHER

NCT03988257 - The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children | Biotech Hunter | Biotech Hunter