The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children

NCT03988257 | Completed Phase 4

• 2 other identifiers: 5FNUT11KB/45/2018
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhoea;Acute

Keywords

Acute diarrhoea; Infectious diarrhoea; Pleuran; Beta-glucan; Duration of diarrhoea; Severity of diarrhoea; Randomized Controlled Trails as Topic

Outcome Measures

Primary Outcomes (1)

• The duration of diarrhoea.

  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.

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

Secondary Outcomes (6)

• The duration of hospitalization.

  Daily assessment until the 14th day of observation.

• The number of days with need for intravenous rehydration.

  Daily assessment until the discharge from hospital.

• The number of hours until normalization of stools consistency ( type 2-5 according to Bristol Stool Consistency Scale).

  Daily assessment until the 14th day of observation.

• The number of hours until the normalization of number of stools per day (<3 stools/ day).

  Daily assessment until the 14th day of observation.

• The percentage of children with moderate and severe diarrhea.

  Assessed after the 14th day of the observation.

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Dietary Supplement: Imunoglukan PH4

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (vitamin C syrup)

Interventions

Imunoglukan PH4 DIETARY_SUPPLEMENT

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.

Experimental group

Placebo (vitamin C syrup) DIETARY_SUPPLEMENT

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.

Control group

Eligibility Criteria

• Age: 13 Months - 120 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Caretaker's written, informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Nutricia Foundation: collaborator
• Pleuran, s.r.o.: collaborator

Study Sites (1)

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

Warsaw, 02-091, Poland

Location

Related Publications (15)

• Guarino A, Ashkenazi S, Gendrel D, Lo Vecchio A, Shamir R, Szajewska H; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; European Society for Pediatric Infectious Diseases. European Society for Pediatric Gastroenterology, Hepatology, and Nutrition/European Society for Pediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: update 2014. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):132-52. doi: 10.1097/MPG.0000000000000375.

  PMID: 24739189 BACKGROUND

• Freedman SB, Ali S, Oleszczuk M, Gouin S, Hartling L. Treatment of acute gastroenteritis in children: an overview of systematic reviews of interventions commonly used in developed countries. Evid Based Child Health. 2013 Jul;8(4):1123-37. doi: 10.1002/ebch.1932.

  PMID: 23877938 BACKGROUND

• National Collaborating Centre for Women's and Children's Health (UK). Diarrhoea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger than 5 Years. London: RCOG Press; 2009 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK63844/

  PMID: 22132432 BACKGROUND

• Hojsak I, Fabiano V, Pop TL, Goulet O, Zuccotti GV, Cokugras FC, Pettoello-Mantovani M, Kolacek S. Guidance on the use of probiotics in clinical practice in children with selected clinical conditions and in specific vulnerable groups. Acta Paediatr. 2018 Jun;107(6):927-937. doi: 10.1111/apa.14270. Epub 2018 Apr 16.

  PMID: 29446865 BACKGROUND

• Szajewska H, Guarino A, Hojsak I, Indrio F, Kolacek S, Shamir R, Vandenplas Y, Weizman Z; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Use of probiotics for management of acute gastroenteritis: a position paper by the ESPGHAN Working Group for Probiotics and Prebiotics. J Pediatr Gastroenterol Nutr. 2014 Apr;58(4):531-9. doi: 10.1097/MPG.0000000000000320.

  PMID: 24614141 BACKGROUND

• van den Berg J, Berger MY. Guidelines on acute gastroenteritis in children: a critical appraisal of their quality and applicability in primary care. BMC Fam Pract. 2011 Dec 2;12:134. doi: 10.1186/1471-2296-12-134.

  PMID: 22136388 BACKGROUND

• Di Luzio NR. Update on the immunomodulating activities of glucans. Springer Semin Immunopathol. 1985;8(4):387-400. doi: 10.1007/BF01857392. No abstract available.

  PMID: 4089757 BACKGROUND

• Chan GC, Chan WK, Sze DM. The effects of beta-glucan on human immune and cancer cells. J Hematol Oncol. 2009 Jun 10;2:25. doi: 10.1186/1756-8722-2-25.

  PMID: 19515245 BACKGROUND

• Jesenak M, Majtan J, Rennerova Z, Kyselovic J, Banovcin P, Hrubisko M. Immunomodulatory effect of pleuran (beta-glucan from Pleurotus ostreatus) in children with recurrent respiratory tract infections. Int Immunopharmacol. 2013 Feb;15(2):395-9. doi: 10.1016/j.intimp.2012.11.020. Epub 2012 Dec 20.

  PMID: 23261366 BACKGROUND

• Jesenak M, Urbancek S, Majtan J, Banovcin P, Hercogova J. beta-Glucan-based cream (containing pleuran isolated from pleurotus ostreatus) in supportive treatment of mild-to-moderate atopic dermatitis. J Dermatolog Treat. 2016 Aug;27(4):351-4. doi: 10.3109/09546634.2015.1117565. Epub 2015 Dec 10.

  PMID: 26654776 BACKGROUND

• Bobovcak M, Kuniakova R, Gabriz J, Majtan J. Effect of Pleuran (beta-glucan from Pleurotus ostreatus) supplementation on cellular immune response after intensive exercise in elite athletes. Appl Physiol Nutr Metab. 2010 Dec;35(6):755-62. doi: 10.1139/H10-070.

  PMID: 21164546 BACKGROUND

• Bergendiova K, Tibenska E, Majtan J. Pleuran (beta-glucan from Pleurotus ostreatus) supplementation, cellular immune response and respiratory tract infections in athletes. Eur J Appl Physiol. 2011 Sep;111(9):2033-40. doi: 10.1007/s00421-011-1837-z. Epub 2011 Jan 20.

  PMID: 21249381 BACKGROUND

• Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

  PMID: 9299672 BACKGROUND

• Wzorek-Lyczko K, Piwowarczyk A, Wozniak W, Kuchar E, Szymanski H. A randomised trial of pleuran in paediatric acute gastroenteritis. Sci Rep. 2025 May 15;15(1):16912. doi: 10.1038/s41598-025-94893-3.

  PMID: 40374943 DERIVED

• Wzorek-Lyczko K, Piwowarczyk A, Kuchar E. Protocol of the study: the effectiveness of pleuran in the treatment of acute gastroenteritis in children-a randomised, placebo-controlled, double-blind trial (EPTAGE). BMJ Open. 2021 Mar 11;11(3):e042370. doi: 10.1136/bmjopen-2020-042370.

  PMID: 33707267 DERIVED

MeSH Terms

Conditions

Dysentery

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ernest Kuchar, MD PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients, their caregivers, researchers, physicians, nurses, the statistician will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 17, 2019
• Study Start: June 24, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2022
• Last Updated: January 11, 2023

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Documents listed above will be available during the Study commencement, while individual deidentified participant data after the Study results publication, for a minimum of 5 years.
• Access Criteria: The study protocol will be publicly available. Other documents listed above (Statistical Analysis Plan, Clinical Research Form, Informed Consent Form) will be available on request for medical journal editors, The Bioethical Committee of The Medical University of Warsaw, and the Study Primary Sponsor (The Medical University of Warsaw) for the purpose of the Study methodology and ethics monitoring.

Locations

PL (1)