Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

Acute Gastroenteritis Clinical Trial

Official title:

Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280759
• Other study ID #: KB56/2014
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2014
• Last updated: July 5, 2017
• Start date: November 2014
• Est. completion date: June 10, 2017

Study information

• Verified date: July 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 10, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

Drug:
• Gelatin Tannate

• Placebo
Placebo consists of an identical formulation, except active substance

Locations

Country	Name	City	State
Poland	Department of Paediatrics, The Medical University of Warsaw, Poland	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need of intravenous rehydration due to diarrhea		7 days
Secondary	Need of hospitalization in outpatients		7 days
Secondary	Vomiting		How many times for 7days
Secondary	Weight gain		7 days
Secondary	Diarrhea recurrence		7 days
Secondary	Frequency of watery stools		7 days
Secondary	Adverse effects		7 days
Secondary	Severity of diarrhea due to modified Vesikari score		7 days