Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gelatin Tannate

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.

Group Type ACTIVE_COMPARATOR

Gelatin Tannate

Intervention Type DRUG

Placebo

Placebo consists of an identical formulation, except active substance.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo consists of an identical formulation, except active substance

Interventions

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Gelatin Tannate

Intervention Type DRUG

Placebo

Placebo consists of an identical formulation, except active substance

Intervention Type DRUG

Eligibility Criteria

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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)

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No