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Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

Primary Purpose

Acute Gastroenteritis

Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Gelatin Tannate
Placebo
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastroenteritis focused on measuring diarrhea, gelatin tannate, acute gastroenteritis

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children < 5 years old
  • diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
  • inform consent sign

Exclusion Criteria:

  • regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
  • underlying gastrointestinal tract disorder presenting with diarrhea
  • breastfeeding >50%
  • malnutrition (weight/high <3pc)

Sites / Locations

  • Department of Paediatrics, The Medical University of Warsaw, Poland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gelatin Tannate

Placebo

Arm Description

Gelatin Tannate: 4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years.

Placebo consists of an identical formulation, except active substance.

Outcomes

Primary Outcome Measures

Duration of diarrhea
time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours

Secondary Outcome Measures

Need of intravenous rehydration due to diarrhea
Need of hospitalization in outpatients
Vomiting
Weight gain
Diarrhea recurrence
Frequency of watery stools
Adverse effects
Severity of diarrhea due to modified Vesikari score

Full Information

First Posted
October 29, 2014
Last Updated
July 5, 2017
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT02280759
Brief Title
Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
Official Title
Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 10, 2017 (Actual)
Study Completion Date
June 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis
Keywords
diarrhea, gelatin tannate, acute gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gelatin Tannate
Arm Type
Active Comparator
Arm Description
Gelatin Tannate: 4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo consists of an identical formulation, except active substance.
Intervention Type
Drug
Intervention Name(s)
Gelatin Tannate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo consists of an identical formulation, except active substance
Primary Outcome Measure Information:
Title
Duration of diarrhea
Description
time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Need of intravenous rehydration due to diarrhea
Time Frame
7 days
Title
Need of hospitalization in outpatients
Time Frame
7 days
Title
Vomiting
Time Frame
How many times for 7days
Title
Weight gain
Time Frame
7 days
Title
Diarrhea recurrence
Time Frame
7 days
Title
Frequency of watery stools
Time Frame
7 days
Title
Adverse effects
Time Frame
7 days
Title
Severity of diarrhea due to modified Vesikari score
Time Frame
7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children < 5 years old diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days inform consent sign Exclusion Criteria: regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission underlying gastrointestinal tract disorder presenting with diarrhea breastfeeding >50% malnutrition (weight/high <3pc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Szajewska, Profesor
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Paediatrics, The Medical University of Warsaw, Poland
City
Warsaw
ZIP/Postal Code
01-183
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29794092
Citation
Kolodziej M, Bebenek D, Konarska Z, Szajewska H. Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial. BMJ Open. 2018 May 24;8(5):e020205. doi: 10.1136/bmjopen-2017-020205.
Results Reference
derived
PubMed Identifier
26895988
Citation
Michalek D, Kolodziej M, Konarska Z, Szajewska H. Efficacy and safety of gelatine tannate for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial. BMJ Open. 2016 Feb 19;6(2):e010530. doi: 10.1136/bmjopen-2015-010530. Erratum In: BMJ Open. 2017 Aug 11;7(8):e010530corr1.
Results Reference
derived

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Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

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