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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymethylsiloxane | Dietary Supplement |
|
| |
| Lactobacillus reuteri |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroenteritis symptoms duration. | Duration of the loose stools, fever and vomiting. | 1-8 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the hospitalization of any kind. | Duration of the classic hospitalization or duration of daily hospital attending. | 30 days |
| Total number of loose stools. | The total number of loose stools are measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goran Tešović, MD, PhD | University Clinic for Infectious Diseases, Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic for Infectious Diseases | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33409259 | Derived | Markovinovic L, Knezovic I, Kniewald T, Stemberger Maric L, Trkulja V, Tesovic G. Enteroadsorbent Polymethylsiloxane Polyhydrate vs. Probiotic Lactobacillus reuteri DSM 17938 in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers, a Randomized Controlled Trial. Front Pediatr. 2020 Dec 21;8:553960. doi: 10.3389/fped.2020.553960. eCollection 2020. |
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The data are available for ten years.
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| ID | Term |
|---|---|
| C078211 | polymethylsiloxane |
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| Dietary Supplement |
|
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| 8 days |