Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

Medical University of Warsaw

Status and phase: Completed; Phase 1

Conditions: Acute Gastroenteritis

Treatments: Drug: Gelatin Tannate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02280759

KB56/2014

Details and patient eligibility

About

Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.

Enrollment: 72 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children < 5 years old
• diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
• inform consent sign

Exclusion criteria

• regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
• underlying gastrointestinal tract disorder presenting with diarrhea
• breastfeeding >50%
• malnutrition (weight/high <3pc)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Gelatin Tannate

Active Comparator group

Description:

Gelatin Tannate: 4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years.

Treatment:

Drug: Gelatin Tannate

Placebo

Placebo Comparator group

Description:

Placebo consists of an identical formulation, except active substance.

Treatment:

Drug: Placebo