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

Study Overview
=================
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.

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

Conditions
-----------------
Rotavirus Gastroenteritis

Intervention / Treatment
-----------------
* Dietary Supplement: Polymethylsiloxane
* Dietary Supplement: Lactobacillus reuteri


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polymethylsiloxane<br>Polymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days. | Dietary Supplement: Polymethylsiloxane<br> <br> * Other names: Enterosgel;|
| Active Comparator: Lactobacillus reuteri<br>Probiotic Lactobacillus reuteri (BioGaia) is given 3 x 20 drops (which means 3 x 400,000.000 CFU) per day for five days. | Dietary Supplement: Lactobacillus reuteri<br> <br> * Other names: BioGaia;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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