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

Phase 4

Completed

• Conditions: Rotavirus Gastroenteritis
• Interventions: Dietary Supplement: Polymethylsiloxane; Dietary Supplement: Lactobacillus reuteri

• Registration Number: NCT04116307
• Lead Sponsor: University Hospital for Infectious Diseases, Croatia

Brief Summary

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).

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 Timeline

• Study Start: 2013-01-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2019-09
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Study First Posted: 2019-10-04
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polymethylsiloxane	Polymethylsiloxane	Polymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days.
Lactobacillus reuteri	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.

Primary Outcome Measures

Name	Time	Method
Gastroenteritis symptoms duration.	1-8 days.	Duration of the loose stools, fever and vomiting.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinic for Infectious Diseases; 🇭🇷 Zagreb, Croatia