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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04116307

Enrollment

130

Registered

2019-10-04

Start date

2013-01-01

Completion date

2017-05-31

Last updated

2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotavirus Gastroenteritis

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.

Interventions

DIETARY_SUPPLEMENTPolymethylsiloxane

DIETARY_SUPPLEMENTLactobacillus reuteri

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 3 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026