Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis
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|ClinicalTrials.gov Identifier: NCT04116307|
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rotavirus Gastroenteritis||Dietary Supplement: Polymethylsiloxane Dietary Supplement: Lactobacillus reuteri||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Clinical Efficacy of Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers.|
|Actual Study Start Date :||January 1, 2013|
|Actual Primary Completion Date :||May 31, 2017|
|Actual Study Completion Date :||May 31, 2017|
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
Other Name: Enterosgel
Active Comparator: 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.
Dietary Supplement: Lactobacillus reuteri
Other Name: BioGaia
- Gastroenteritis symptoms duration. [ Time Frame: 1-8 days. ]Duration of the loose stools, fever and vomiting.
- Duration of the hospitalization of any kind. [ Time Frame: 30 days ]Duration of the classic hospitalization or duration of daily hospital attending.
- Total number of loose stools. [ Time Frame: 8 days ]The total number of loose stools are measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116307
|University Clinic for Infectious Diseases|
|Zagreb, Croatia, 10000|
|Principal Investigator:||Goran Tešović, MD, PhD||University Clinic for Infectious Diseases, Zagreb|