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Completed

NCT Number: NCT02644200

Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

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.

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Key information

Conditions

Acute Gastroenteritis

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatrics, Sapienza University of Rome

Rome, RM, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gelatin tannate

Device

Other names: Gelenterum

Primary outcomes

  1. Number of stools

    Time frame: 48 hours

    difference in the number of stools after treatment initiation in the 2 arms

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: GT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 31, 2015
Registry last updated
Dec 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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