Trial | NCT04116307  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    130
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).
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.
Study Started
Jan 01
2013
Primary Completion
May 31
2017
Study Completion
May 31
2017
Last Update
Oct 04
2019

Dietary Supplement Polymethylsiloxane

  • Other names: Enterosgel

Dietary Supplement Lactobacillus reuteri

  • Other names: BioGaia

Polymethylsiloxane Experimental

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

Lactobacillus reuteri Active Comparator

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

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
No Results Posted