Comparison of Clinical Efficacy of Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Gastroenteritis symptoms duration.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Polymethylsiloxane
Polymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days.
Intervention: Polymethylsiloxane (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.
Intervention: Lactobacillus reuteri (Dietary Supplement)
Outcomes
Primary Outcomes
Gastroenteritis symptoms duration.
Time Frame: 1-8 days.
Duration of the loose stools, fever and vomiting.
Secondary Outcomes
- Total number of loose stools.(8 days)
- Duration of the hospitalization of any kind.(30 days)