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Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

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ClinicalTrials.gov Identifier: NCT02280759
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2014
Actual Primary Completion Date : June 10, 2017
Actual Study Completion Date : June 10, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280759


Locations
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Poland
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, Poland, 01-183
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Hanna Szajewska, Profesor Medical University of Warsaw
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02280759    
Other Study ID Numbers: KB56/2014
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Keywords provided by Medical University of Warsaw:
diarrhea, gelatin tannate, acute gastroenteritis
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases