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Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis (GT)

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ClinicalTrials.gov Identifier: NCT02644200
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Marina Aloi, University of Roma La Sapienza

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Gastroenteritis Device: Gelatin tannate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis: a Prospective, Randomized, Single-blind Controlled Clinical Trial
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Arm Intervention/treatment
No Intervention: ORS
Controls treated with oral rehydration solution (standard therapy)
Active Comparator: ORS+GT
Group treated with oral rehydration solution plus gelatin tannate
Device: Gelatin tannate
Other Name: Gelenterum




Primary Outcome Measures :
  1. Number of stools [ Time Frame: 48 hours ]
    difference in the number of stools after treatment initiation in the 2 arms


Secondary Outcome Measures :
  1. Duration of diarrhea after treatment initiation in the 2 arms [ Time Frame: 48 hours, 72 hours ]
    The duration of diarrhea was defined as the time in hours from enrolment to the last abnormal (loose or liquid) stool. Last abnormal stool was defined when the child passed to normal stool or no stool for next 24 hours

  2. Time to normalization of stool consistency [ Time Frame: 48 hours, 72 hours ]
    Stool consistency was evaluated on a modified Bristol Stool Form Scale for Children (m-BSFS-C) and defined as: 1: separate hard lumps, like nuts; 2: Sausage-shaped but lumpy; 3: like a sausage or snake, smooth and soft; 4: fluffy pieces with ragged edges, a mushy stool; 5: watery, no solid pieces

  3. Number of visits to the emergency room [ Time Frame: 7 days ]
    need for additional visits during the 7 days of treatment in the 2 arms

  4. Growth [ Time Frame: 7 days ]
    growth parameters in the 2 arms

  5. Adverse events treatment related [ Time Frame: 7 days ]
    Number of participants with drug-related adverse events in the 2 arms



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children of both sex, aged 3 months to 5 years of age
  • Clinical diagnosis of acute gastroenteritis, as defined by having at least 3 loose stools within the previous 24 hours and/or a change in stool consistency to loose or liquid according to Bristol Stool Form Scale for Children (m-BSFS-C) lasting for no longer than 3 days.

Exclusion Criteria:

  • patients with gastroenteritis lasting more than 5 days
  • patients with chronic gastrointestinal conditions
  • patients receiving other antidiarrheal drugs within 2 weeks prior to enrollment (i.e. antibiotics, probiotics, salicylates, loperamide, racecadotril, disomectite)

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): NCT02644200


Locations
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Italy
Department of Pediatrics, Sapienza University of Rome
Rome, RM, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marina Aloi, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02644200    
Other Study ID Numbers: 4-2015
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Dextrans
Anticoagulants
Plasma Substitutes
Blood Substitutes