Skip to main content
OpenTrials
Completed

NCT Number: NCT02280759

Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Gastroenteritis Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, 01-183, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gelatin Tannate

Drug

Placebo

Drug

Placebo consists of an identical formulation, except active substance

Primary outcomes

  1. Duration of diarrhea

    Time frame: 7 days

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

Secondary outcomes

  1. Need of intravenous rehydration due to diarrhea

    Time frame: 7 days

  2. Need of hospitalization in outpatients

    Time frame: 7 days

  3. Vomiting

    Time frame: How many times for 7days

  4. Weight gain

    Time frame: 7 days

  5. Diarrhea recurrence

    Time frame: 7 days

  6. Frequency of watery stools

    Time frame: 7 days

  7. Adverse effects

    Time frame: 7 days

  8. Severity of diarrhea due to modified Vesikari score

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2014
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.