Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

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StatusAbgeschlossen

Sponsoren

University of Roma La Sapienza

KLINISCHE STUDIE: NCT02644200

BioSeek: nct02644200

Schlüsselwörter

Abstrakt

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.

Termine

Zuletzt überprüft:	11/30/2015
Zuerst eingereicht:	12/15/2015
Geschätzte Einschreibung eingereicht:	12/27/2015
Zuerst veröffentlicht:	12/30/2015
Letztes eingereichtes Update:	12/27/2015
Letztes Update veröffentlicht:	12/30/2015
Tatsächliches Startdatum der Studie:	05/31/2013
Geschätztes primäres Abschlussdatum:	05/31/2014
Voraussichtliches Abschlussdatum der Studie:	05/31/2014

Zustand oder Krankheit

Acute Gastroenteritis

Intervention / Behandlung

Device: ORS+GT

Phase

Phase 3

Armgruppen

Arm	Intervention / Behandlung
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: ORS+GT

Zulassungskriterien

Altersberechtigt für das Studium	3 Months Zu 3 Months
Studienberechtigte Geschlechter	All
Akzeptiert gesunde Freiwillige	Ja
Kriterien	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)

Ergebnis

Primäre Ergebnismaße

1. Number of stools [48 hours]

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

Sekundäre Ergebnismaße

1. Duration of diarrhea after treatment initiation in the 2 arms [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 [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 [7 days]

need for additional visits during the 7 days of treatment in the 2 arms

4. Growth [7 days]

growth parameters in the 2 arms

5. Adverse events treatment related [7 days]

Number of participants with drug-related adverse events in the 2 arms

Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

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gastroenteritis