Clinical Trials Logo

Clinical Trial Summary

Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. The aim of this study was to compare the efficacy and safety of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in children with acute gastroenteritis.

This is a single-blind, prospective, randomized and parallel study performed in two Pediatric Services of tertiary referral hospitals. Patients, ages 3 to 36 months with acute gastroenteritis randomized to receive an oral rehydration solution (OR), or an oral rehydration solution plus gelatin tannate (OR+G). The primary outcomes evaluated were: the number of bowel movements after 48 and 72 hours after initiating treatments. Secondary outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two treatments were also recorded.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02644200
Study type Interventional
Source University of Roma La Sapienza
Contact
Status Completed
Phase Phase 3
Start date June 2013
Completion date June 2014

See also
  Status Clinical Trial Phase
Completed NCT04682860 - Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide Phase 4
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT01577043 - Efficacy of Racecadotril in Acute Watery Diarrhea in Children Phase 4
Completed NCT03234777 - Evaluating a Knowledge Translation Tool for Parents N/A
Not yet recruiting NCT02619201 - Antiemetic Efficacy of Ondansetron Versus Metoclopramide Phase 3
Completed NCT02280759 - Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children. Phase 1
Completed NCT06090708 - Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis N/A
Recruiting NCT05270291 - Infectious Etiology of Vomiting in Children With Presumed Acute Gastroenteritis
Completed NCT02025452 - Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis Phase 4
Not yet recruiting NCT06038305 - Prevalence of Anemia and Growth Assessment in Acute Gastroenteritis
Completed NCT02803827 - Optimizing the Management of Acute Diarrhoeal Disease Phase 3
Completed NCT02174874 - Ondansetron Oral Versus Orally Disintegrating Tablets (ODT) N/A
Completed NCT03539913 - Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children Phase 4
Recruiting NCT06137014 - Fortified Oral Rehydration Therapy for Pediatric Diarrhea Phase 1/Phase 2
Completed NCT04463355 - Video Discharge Instructions for Pediatric Gastroenteritis in an Emergency Department N/A
Completed NCT04555200 - Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis
Unknown status NCT02177799 - Surveillance Study of Acute Gastroenteritis in Hospitalized Children in Rural Area in Lebanon N/A
Completed NCT02169817 - Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children Phase 4
Completed NCT01886755 - Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis N/A
Completed NCT01257672 - Symptomatic Treatment of Acute Gastroenteritis Phase 3