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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

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date July 6, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
  • Need of intravenous rehydration due to diarrhea [ Time Frame: 7 days ]
  • Need of hospitalization in outpatients [ Time Frame: 7 days ]
  • Vomiting [ Time Frame: How many times for 7days ]
  • Weight gain [ Time Frame: 7 days ]
  • Diarrhea recurrence [ Time Frame: 7 days ]
  • Frequency of watery stools [ Time Frame: 7 days ]
  • Adverse effects [ Time Frame: 7 days ]
  • Severity of diarrhea due to modified Vesikari score [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
Official Title  ICMJE Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Gastroenteritis
Intervention  ICMJE
  • Drug: Gelatin Tannate
  • Drug: Placebo
    Placebo consists of an identical formulation, except active substance
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Gelatin Tannate
  • Placebo Comparator: Placebo
    Placebo consists of an identical formulation, except active substance.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
158
Actual Study Completion Date  ICMJE June 10, 2017
Actual Primary Completion Date June 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280759
Other Study ID Numbers  ICMJE KB56/2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hanna Szajewska, Profesor Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP