Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

Study Overview
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Brief Summary
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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.

Official Title
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Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis: a Prospective, Randomized, Single-blind Controlled Clinical Trial

Conditions
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Acute Gastroenteritis

Intervention / Treatment
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* Device: Gelatin tannate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ORS<br>Controls treated with oral rehydration solution (standard therapy) | |
| Active Comparator: ORS+GT<br>Group treated with oral rehydration solution plus gelatin tannate | Device: Gelatin tannate<br> <br> * Other names: Gelenterum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stools | difference in the number of stools after treatment initiation in the 2 arms | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 48 hours, 72 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 | 48 hours, 72 hours | 
| Number of visits to the emergency room | need for additional visits during the 7 days of treatment in the 2 arms | 7 days | 
| Growth | growth parameters in the 2 arms | 7 days | 
| Adverse events treatment related | Number of participants with drug-related adverse events in the 2 arms | 7 days |