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

Primary Purpose

Rotavirus Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Polymethylsiloxane
Lactobacillus reuteri
Sponsored by
University Hospital for Infectious Diseases, Croatia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotavirus Gastroenteritis

Eligibility Criteria

6 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Clinic for Infectious Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Polymethylsiloxane

Lactobacillus reuteri

Arm Description

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

Probiotic Lactobacillus reuteri (BioGaia) is given 3 x 20 drops (which means 3 x 400,000.000 CFU) per day for five days.

Outcomes

Primary Outcome Measures

Gastroenteritis symptoms duration.
Duration of the loose stools, fever and vomiting.

Secondary Outcome Measures

Duration of the hospitalization of any kind.
Duration of the classic hospitalization or duration of daily hospital attending.
Total number of loose stools.
The total number of loose stools are measured.

Full Information

First Posted
September 30, 2019
Last Updated
October 2, 2019
Sponsor
University Hospital for Infectious Diseases, Croatia
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1. Study Identification

Unique Protocol Identification Number
NCT04116307
Brief Title
Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis
Official Title
Comparison of Clinical Efficacy of Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital for Infectious Diseases, Croatia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polymethylsiloxane
Arm Type
Experimental
Arm Description
Polymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days.
Arm Title
Lactobacillus reuteri
Arm Type
Active Comparator
Arm Description
Probiotic Lactobacillus reuteri (BioGaia) is given 3 x 20 drops (which means 3 x 400,000.000 CFU) per day for five days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Polymethylsiloxane
Other Intervention Name(s)
Enterosgel
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri
Other Intervention Name(s)
BioGaia
Primary Outcome Measure Information:
Title
Gastroenteritis symptoms duration.
Description
Duration of the loose stools, fever and vomiting.
Time Frame
1-8 days.
Secondary Outcome Measure Information:
Title
Duration of the hospitalization of any kind.
Description
Duration of the classic hospitalization or duration of daily hospital attending.
Time Frame
30 days
Title
Total number of loose stools.
Description
The total number of loose stools are measured.
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 6-36 months proven rotavirus gastroenteritis symptom duration less than 48 hours informed consent of the parents/caregivers Exclusion Criteria: rotavirus vaccination rotavirus infection in a patient's history severe acute or chronic illness with possible influence on rotavirus gastroenteritis outcome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran Tešović, MD, PhD
Organizational Affiliation
University Clinic for Infectious Diseases, Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic for Infectious Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
The data are available for ten years.
Citations:
PubMed Identifier
33409259
Citation
Markovinovic L, Knezovic I, Kniewald T, Stemberger Maric L, Trkulja V, Tesovic G. Enteroadsorbent Polymethylsiloxane Polyhydrate vs. Probiotic Lactobacillus reuteri DSM 17938 in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers, a Randomized Controlled Trial. Front Pediatr. 2020 Dec 21;8:553960. doi: 10.3389/fped.2020.553960. eCollection 2020.
Results Reference
derived

Learn more about this trial

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

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