Status:

COMPLETED

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

Lead Sponsor:

University Hospital for Infectious Diseases, Croatia

Conditions:

Rotavirus Gastroenteritis

Eligibility:

All Genders

6-3 years

Phase:

PHASE4

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, polymethyl...

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 possibl...

Eligibility Criteria

Inclusion

  • age 6-36 months
  • proven rotavirus gastroenteritis
  • symptom duration less than 48 hours
  • informed consent of the parents/caregivers

Exclusion

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

Key Trial Info

Start Date :

January 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2017

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT04116307

Start Date

January 1 2013

End Date

May 31 2017

Last Update

October 4 2019

Active Locations (1)

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1

University Clinic for Infectious Diseases

Zagreb, Croatia, 10000