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Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04116307
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital for Infectious Diseases, Croatia

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).

Condition or disease Intervention/treatment Phase
Rotavirus Gastroenteritis Dietary Supplement: Polymethylsiloxane Dietary Supplement: Lactobacillus reuteri Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arm Intervention/treatment
Experimental: Polymethylsiloxane
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




Primary Outcome Measures :
  1. Gastroenteritis symptoms duration. [ Time Frame: 1-8 days. ]
    Duration of the loose stools, fever and vomiting.


Secondary Outcome Measures :
  1. Duration of the hospitalization of any kind. [ Time Frame: 30 days ]
    Duration of the classic hospitalization or duration of daily hospital attending.

  2. Total number of loose stools. [ Time Frame: 8 days ]
    The total number of loose stools are measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 6-36 months
  2. proven rotavirus gastroenteritis
  3. symptom duration less than 48 hours
  4. informed consent of the parents/caregivers

Exclusion Criteria:

  1. rotavirus vaccination
  2. rotavirus infection in a patient's history
  3. severe acute or chronic illness with possible influence on rotavirus gastroenteritis outcome

Information from the National Library of Medicine

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


Locations
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Croatia
University Clinic for Infectious Diseases
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital for Infectious Diseases, Croatia
Investigators
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Principal Investigator: Goran Tešović, MD, PhD University Clinic for Infectious Diseases, Zagreb

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Responsible Party: University Hospital for Infectious Diseases, Croatia
ClinicalTrials.gov Identifier: NCT04116307    
Other Study ID Numbers: UHID-03
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data are available for ten years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases