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Completed

NCT Number: NCT04116307

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

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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Key information

Conditions

Rotavirus Gastroenteritis

Age range

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Clinic for Infectious Diseases

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polymethylsiloxane

Dietary Supplement

Other names: Enterosgel

Lactobacillus reuteri

Dietary Supplement

Other names: BioGaia

Primary outcomes

  1. Gastroenteritis symptoms duration.

    Time frame: 1-8 days.

    Duration of the loose stools, fever and vomiting.

Secondary outcomes

  1. Duration of the hospitalization of any kind.

    Time frame: 30 days

    Duration of the classic hospitalization or duration of daily hospital attending.

  2. Total number of loose stools.

    Time frame: 8 days

    The total number of loose stools are measured.

Sponsors and collaborators

Lead sponsor

University Hospital for Infectious Diseases, Croatia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2019
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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