Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Completed
• CT.gov ID: NCT02280759
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Duration (Months): 31.3
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Gastroenteritis	Drug: Gelatin Tannate; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Jun 10, 2017
• Actual Study Completion Date: Jun 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Gelatin Tannate
Placebo Comparator: Placebo Placebo consists of an identical formulation, except active substance.	Drug: Placebo; Placebo consists of an identical formulation, except active substance

Outcome Measures

Primary Outcome Measures

1. Duration of diarrhea [7 days]

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

Secondary Outcome Measures

1. Need of intravenous rehydration due to diarrhea [7 days]

2. Need of hospitalization in outpatients [7 days]

3. Vomiting [How many times for 7days]

4. Weight gain [7 days]

5. Diarrhea recurrence [7 days]

6. Frequency of watery stools [7 days]

7. Adverse effects [7 days]

8. Severity of diarrhea due to modified Vesikari score [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Paediatrics, The Medical University of Warsaw, Poland	Warsaw		Poland	01-183

Sponsors and Collaborators

• Medical University of Warsaw

Investigators

• Principal Investigator: Hanna Szajewska, Profesor, Medical University of Warsaw

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT02280759
• Other Study ID Numbers: KB56/2014
• First Posted: Oct 31, 2014
• Last Update Posted: Jul 6, 2017
• Last Verified: Jul 1, 2017

• Keywords provided by Medical University of Warsaw: diarrhea, gelatin tannate, acute gastroenteritis
• Additional relevant MeSH terms: Gastroenteritis

Study Results

No Results Posted as of Jul 6, 2017