Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis
NCT ID: NCT02644200
Last Updated: 2015-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2013-06-30
2014-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ORS
Controls treated with oral rehydration solution (standard therapy)
No interventions assigned to this group
ORS+GT
Group treated with oral rehydration solution plus gelatin tannate
Gelatin tannate
Interventions
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Gelatin tannate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 chronic gastrointestinal conditions
* patients receiving other antidiarrheal drugs within 2 weeks prior to enrollment (i.e. antibiotics, probiotics, salicylates, loperamide, racecadotril, disomectite)
3 Months
5 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Marina Aloi
MD, PhD
Locations
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Department of Pediatrics, Sapienza University of Rome
Rome, RM, Italy
Countries
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References
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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.
Other Identifiers
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4-2015
Identifier Type: -
Identifier Source: org_study_id