Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis
Comparison of Clinical Efficacy of Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis in Infants and Toddlers.
1 other identifier
interventional
130
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedFirst Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 4, 2019
CompletedOctober 4, 2019
September 1, 2019
4.4 years
September 30, 2019
October 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Gastroenteritis symptoms duration.
Duration of the loose stools, fever and vomiting.
1-8 days.
Secondary Outcomes (2)
Duration of the hospitalization of any kind.
30 days
Total number of loose stools.
8 days
Study Arms (2)
Polymethylsiloxane
EXPERIMENTALPolymethylsiloxane (Enterosgel) is given 3 x 10 g for the initial two days, and 3 x 5 g for the next three days.
Lactobacillus reuteri
ACTIVE COMPARATORProbiotic Lactobacillus reuteri (BioGaia) is given 3 x 20 drops (which means 3 x 400,000.000 CFU) per day for five days.
Interventions
Eligibility Criteria
You may qualify if:
- age 6-36 months
- proven rotavirus gastroenteritis
- symptom duration less than 48 hours
- informed consent of the parents/caregivers
You may not qualify if:
- rotavirus vaccination
- rotavirus infection in a patient's history
- severe acute or chronic illness with possible influence on rotavirus gastroenteritis outcome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinic for Infectious Diseases
Zagreb, 10000, Croatia
Related Publications (1)
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.
PMID: 33409259DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Goran Tešović, MD, PhD
University Clinic for Infectious Diseases, Zagreb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 4, 2019
Study Start
January 1, 2013
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
October 4, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The data are available for ten years.