Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis (GT)
Primary Purpose
Acute Gastroenteritis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Gelatin tannate
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gastroenteritis
Eligibility 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)
Sites / Locations
- Department of Pediatrics, Sapienza University of Rome
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
ORS
ORS+GT
Arm Description
Controls treated with oral rehydration solution (standard therapy)
Group treated with oral rehydration solution plus gelatin tannate
Outcomes
Primary Outcome Measures
Number of stools
difference in the number of stools after treatment initiation in the 2 arms
Secondary Outcome Measures
Duration of diarrhea after treatment initiation in the 2 arms
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
Time to normalization of stool consistency
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
Number of visits to the emergency room
need for additional visits during the 7 days of treatment in the 2 arms
Growth
growth parameters in the 2 arms
Adverse events treatment related
Number of participants with drug-related adverse events in the 2 arms
Full Information
NCT ID
NCT02644200
First Posted
December 16, 2015
Last Updated
December 28, 2015
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02644200
Brief Title
Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis
Acronym
GT
Official Title
Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis: a Prospective, Randomized, Single-blind Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ORS
Arm Type
No Intervention
Arm Description
Controls treated with oral rehydration solution (standard therapy)
Arm Title
ORS+GT
Arm Type
Active Comparator
Arm Description
Group treated with oral rehydration solution plus gelatin tannate
Intervention Type
Device
Intervention Name(s)
Gelatin tannate
Other Intervention Name(s)
Gelenterum
Primary Outcome Measure Information:
Title
Number of stools
Description
difference in the number of stools after treatment initiation in the 2 arms
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Duration of diarrhea after treatment initiation in the 2 arms
Description
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
Time Frame
48 hours, 72 hours
Title
Time to normalization of stool consistency
Description
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
Time Frame
48 hours, 72 hours
Title
Number of visits to the emergency room
Description
need for additional visits during the 7 days of treatment in the 2 arms
Time Frame
7 days
Title
Growth
Description
growth parameters in the 2 arms
Time Frame
7 days
Title
Adverse events treatment related
Description
Number of participants with drug-related adverse events in the 2 arms
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Department of Pediatrics, Sapienza University of Rome
City
Rome
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28000174
Citation
Mennini M, Tolone C, Frassanito A, Midulla F, Cucchiara S, Aloi M. Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial. Paediatr Drugs. 2017 Apr;19(2):131-137. doi: 10.1007/s40272-016-0207-z.
Results Reference
derived
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Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis
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