NCT04116307

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: University Hospital for Infectious Diseases, Croatia · Academic / Other
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polymethylsiloxane
DIETARY_SUPPLEMENT	Lactobacillus reuteri

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2019-10-04
• Last updated: 2019-10-04

Locations

1 site across 1 country: Croatia