Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2014
Typical duration for phase_1
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
First Submitted
Initial submission to the registry
October 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2017
CompletedJuly 6, 2017
July 1, 2017
2.6 years
October 29, 2014
July 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of diarrhea
time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours
7 days
Secondary Outcomes (8)
Need of intravenous rehydration due to diarrhea
7 days
Need of hospitalization in outpatients
7 days
Vomiting
How many times for 7days
Weight gain
7 days
Diarrhea recurrence
7 days
- +3 more secondary outcomes
Study Arms (2)
Gelatin Tannate
ACTIVE COMPARATORGelatin 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
PLACEBO COMPARATORPlacebo consists of an identical formulation, except active substance.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, 01-183, Poland
Related Publications (2)
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.
PMID: 29794092DERIVEDMichalek 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.
PMID: 26895988DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanna Szajewska, Profesor
Medical University of Warsaw
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2014
First Posted
October 31, 2014
Study Start
November 1, 2014
Primary Completion
June 10, 2017
Study Completion
June 10, 2017
Last Updated
July 6, 2017
Record last verified: 2017-07