Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis

Comparison of Clinical Efficacy of Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers.

This study evaluates a new drug, new enteroadsorbent polymethylsiloxane (Enterosgel) in the treatment of rotavirus gastroenteritis in children. Half of the participants received a new drug, polymethylsiloxane and half of the participants received standard treatment - probiotic L. reuteri (BioGaia).

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis
• Intervention / Treatment: Dietary supplement: Polymethylsiloxane; Dietary supplement: Lactobacillus reuteri

Detailed Description

Polymethylsiloxane and probiotic L. reuteri both hasten symptoms of the rotavirus gastroenteritis but they do so by a different mode of action.

Polymethylsiloxane is an enteroadsorbent and it possibly acts by adsorption of viruses and doing so it prevents binding rotaviruses for enterocytes. Another mode of action can be forming a thin layer over the mucosal surfaces thus protects them from various damaging factors.

Probiotics help the healing of the intestinal mucosa presumably in few ways - by normalization of gut flora, by competition with pathogen bacteria for binding sites and nutrients and by stimulation of intestinal immune system.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University Clinic for Infectious Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age 6-36 months
2. proven rotavirus gastroenteritis
3. symptom duration less than 48 hours
4. informed consent of the parents/caregivers

Exclusion Criteria:

1. rotavirus vaccination
2. rotavirus infection in a patient's history
3. severe acute or chronic illness with possible influence on rotavirus gastroenteritis outcome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polymethylsiloxane; Polymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days.	Dietary supplement: Polymethylsiloxane; Other Names: Enterosgel
Active Comparator: Lactobacillus reuteri; Probiotic Lactobacillus reuteri (BioGaia) is given 3 x 20 drops (which means 3 x 400,000.000 CFU) per day for five days.	Dietary supplement: Lactobacillus reuteri; Other Names: BioGaia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroenteritis symptoms duration.	Duration of the loose stools, fever and vomiting.	1-8 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the hospitalization of any kind.	Duration of the classic hospitalization or duration of daily hospital attending.	30 days
Total number of loose stools.	The total number of loose stools are measured.	8 days

Collaborators and Investigators

• Sponsor: University Hospital for Infectious Diseases, Croatia
• Investigators: Principal Investigator: Goran Tešović, MD, PhD, University Clinic for Infectious Diseases, Zagreb

Publications and helpful links

General Publications

• Markovinovic L, Knezovic I, Kniewald T, Stemberger Maric L, Trkulja V, Tesovic G. Enteroadsorbent Polymethylsiloxane Polyhydrate vs. Probiotic Lactobacillus reuteri DSM 17938 in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers, a Randomized Controlled Trial. Front Pediatr. 2020 Dec 21;8:553960. doi: 10.3389/fped.2020.553960. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: UHID-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: The data are available for ten years.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No