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

University Hospital for Infectious Diseases, Croatia

Status and phase: Completed; Phase 4

Conditions: Rotavirus Gastroenteritis

Treatments: Dietary Supplement: Lactobacillus reuteri; Dietary Supplement: Polymethylsiloxane

Study type: Interventional

Funder types: Other

Identifiers

NCT04116307

UHID-03

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Polymethylsiloxane

Experimental group

Description:

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

Treatment:

Dietary Supplement: Polymethylsiloxane

Lactobacillus reuteri

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus reuteri