CompletedPhase 4

The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children

Poland27 participantsStarted 2019-06-24

Plain-language summary

Acute gastroenteritis (AGE) is one of the most common causes of children's morbidity and mortality globally. Oral or intravenous rehydration is the only effective treatment in reducing morbidity and mortality rates in AGE. However, new attempts to identify other therapeutic methods to reduce the symptoms of diarrhea are of interest. The administration of pleuran (β- (1,3 / 1,6) -D-glucan) appears to be such an alternative. In Poland, pleuran is being marketed for treating AGE. Its potential immunomodulatory effect is based on the stimulation of both humoral and cellular immunity. The active substance of the product (pleuran) was extracted by unique and patented technology from Pleurotus ostreatus. The substance was previously isolated, identified and chemically characterized by Karacsonyi and Kunia. Pleuran is registered as a diet supplement and distributed in 20 European and non-European countries. The testing for toxicity was performed by the Institute of Preventive and Clinical Medicine of Slovak Medical University (Final Report No. 5-51/04) and the tests were performed in compliance with the criteria of the Directive of Good Laboratory Practice and Directive 2004/10/EC of the European Parliament and the Council of 11th February 2004. To evaluate the efficacy of pleuran in reducing the duration and the severity of AGE symptoms in children, a randomized, placebo-controlled, fully-blind study has been designed. A total of 120 children will be randomly assigned to receive either Imunoglukan PH4 syrup in the experimental group or matching placebo in the control group. The primary outcome measure will be the duration of diarrhea. The statistical analysis of the results will be conducted in both intention-to-treat and per-protocol approach.

Who can participate

Age range13 Months – 120 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 13-120 months, hospitalized or requiring a visit in the emergency department (ED) or outpatient consultation due to AGE, defined as a decrease in the stool consistency (grade 6 or 7 in Bristol Stool Form Scale) and/or an increase in the frequency of stool evacuations \> 3 in 24 hours. * Duration of symptoms 24-72 hours at the time of inclusion. * Caretaker's written, informed consent. Exclusion Criteria: * Duration of symptoms \> 72 hours at the time of inclusion. * Co-occurring other systemic infectious diseases (ex. pneumonia, sepsis). * Diagnosed immune deficiency. * Malnutrition (defined as the body mass index (BMI) \<-2 SDS (Standard Deviation Scores) or \< 3rd percentile based on the World Health Organization (WHO) percentile charts. * Chronic diarrhoeal gastrointestinal disease (inflammatory bowel disease, short bowel syndrome, cystic fibrosis, celiac disease, food allergy). * Use of antibiotics, probiotics, prebiotics or anti-diarrhea (Diosmectite, Racecadotril) medicines within 7 days prior to enrolment into the study. * Use of probiotics, Diosmectite, Racecadotril during the current AGE episode. * Use of pleuran in the 14 days prior to enrolment into the study. * Parallel involvement of the patient in other clinical trials, with the exception of observational studies. * No legal caregivers' consent to participate in the study

What they're measuring

The duration of diarrhoea.

Timeframe: Daily assessment, by the physician and/ or the patient's caregiver during until the 14th day of observation

Trial details

NCT IDNCT03988257

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01