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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2017-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Rotavirus Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Polymethylsiloxane

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

Group Type EXPERIMENTAL

Polymethylsiloxane

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus reuteri

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

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Polymethylsiloxane

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Enterosgel BioGaia

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes