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

Rotavirus Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116307
• Other study ID #: UHID-03
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2013
• Est. completion date: May 31, 2017

Study information

• Verified date: September 2019
• Source: University Hospital for Infectious Diseases, Croatia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Dietary Supplement:
• Polymethylsiloxane

• Lactobacillus reuteri

Locations

Country	Name	City	State
Croatia	University Clinic for Infectious Diseases	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital for Infectious Diseases, Croatia

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroenteritis symptoms duration.	Duration of the loose stools, fever and vomiting.	1-8 days.
Secondary	Duration of the hospitalization of any kind.	Duration of the classic hospitalization or duration of daily hospital attending.	30 days
Secondary	Total number of loose stools.	The total number of loose stools are measured.	8 days