The Effectiveness of Pleuran in Treatment of Acute Gastroenteritis in Children- a Randomized, Placebo-controlled, Double-blind Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- The duration of diarrhoea.
Study Overview
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.
Detailed Description
Study design: This will be a randomized, fully-blind, placebo-controlled trial, with allocation 1:1.
Study population: Children aged 13- 120 months, hospitalized or requiring a visit to the emergency department due to acute gastroenteritis (AGE) lasting at least 24 h, but no longer than 72 h at the time of inclusion to the study.
The setting of the study: The study participants will be recruited from patients requiring hospitalization in 4 paediatric departments or counselling in the emergency department (ED) due to AGE in the Paediatric Teaching Clinical Hospital, the Medical University of Warsaw.
Pre-intervention assessment:
We will evaluate the inclusion and exclusion criteria of the study within 24 hours of hospitalization or ED visit basing on the physical examination and interviews with caregivers. The BMI will be calculated and put on WHO percentiles charts. In order to determine the etiology of AGE, the stool sample will be collected for viral tests (rota-, adeno- and noroviruses markers) before the intervention. If any indication for microbiological stool investigation occurs (the patient in severe condition or with prolonged symptoms in whom specific treatment is considered, or patient with underlying chronic disease), the stool sample will be cultured. The caregivers will be informed about the purpose, methods, safety of the intervention and the course of the study. In order to ensure that the assessed parameters and endpoints are comparable appropriate scales will be applied. To assess the severity of diarrhea, the Modified Vesikari Score will be used. The dehydration degree will be evaluated by means of the WHO scale and the Clinical Dehydration Scale (CDS) recommended by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). The Bristol Stool Form Scale will help to objectify the assessment of stool consistency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
All patients, their caregivers, researchers, physicians, nurses, the statistician will be blinded to the intervention.
Eligibility Criteria
- Ages
- 13 Months to 120 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The duration of diarrhoea.
Time Frame: Daily assessment, by the physician and/ or the patient's caregiver during until the 14th day of observation
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.
Secondary Outcomes
- 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 time until the improvement of the child's general condition according to the caregiver's assessment.(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 the normalization of number of stools per day (<3 stools/ day).(Daily assessment until the 14th day of observation.)
- The duration of hospitalization.(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.)