A Phase 4 interventional study of Polymethylsiloxane and Lactobacillus reuteri in Rotavirus Gastroenteritis, sponsored by University Hospital for Infectious Diseases, Croatia. Completed at 1 site in Croatia. Open to participants aged 6 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by University Hospital for Infectious Diseases, Croatia · Phase 4, Interventional, and Treatment
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.
243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.
This study's enrollment of 130 is close to the median of 126 across 160 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →University Hospital for Infectious Diseases, Croatia is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Polymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days.
Dietary Supplement: Polymethylsiloxane
Probiotic Lactobacillus reuteri (BioGaia) is given 3 x 20 drops (which means 3 x 400,000.000 CFU) per day for five days.
Dietary Supplement: Lactobacillus reuteri
Also known as: Enterosgel
Also known as: BioGaia
Gastroenteritis symptoms duration.
Duration of the loose stools, fever and vomiting.
Time frame: 1-8 days.
Duration of the hospitalization of any kind.
Duration of the classic hospitalization or duration of daily hospital attending.
Time frame: 30 days
Total number of loose stools.
The total number of loose stools are measured.
Time frame: 8 days
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University Hospital for Infectious Diseases, Croatia