Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

Acute Gastroenteritis Clinical Trial

— SABINA  

Official title:

Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539913
• Other study ID #: Sb 184
• Status: Completed
• Phase: Phase 4
• Start date: June 19, 2017
• Est. completion date: June 9, 2018

Study information

• Verified date: January 2019
• Source: Biocodex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Primary Objective:

o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.

• Secondary Objectives:

• To assess the efficacy of the probiotics in improving the frequency and consistency of stools.

• To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.

• To assess the efficacy of the probiotics on the disease severity.

• To assess the safety and tolerability of the studied probiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: June 9, 2018
• Est. primary completion date: June 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

Inclusion Criteria:

• Children of both gender aged between 6 months and 5 years

• Presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days

• Signed informed consent of the legal representatives obtained before any study procedure

• Parents able to fulfill in the stool diary according to the physician's opinion.

Exclusion Criteria:

• Unable to take medication and fluids by mouth

• More than 50% breastfeeding

• Severe malnutrition, defined by a ratio weight/height at/or below -3SD

• Severe dehydration, defined by a need of IV rehydration

• Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection

• Use of prohibited treatments

• Contra-indications to the studied probiotics

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

Biological:
• Probiotic : Saccharomyces boulardii
Treatment for 5 days
• Probiotic : Bacillus clausii
Treatment for 5 days

Locations

Country	Name	City	State
Argentina	Consultario Privado 3	Caba
Argentina	Consultorio Privado 1	Caba
Argentina	Consultorio Privado 2	Caba
Argentina	Consultorio Privado 4	Caba
Argentina	Grupo Pediatrico	Caba
Argentina	Instituto Medico	Río Cuarto	Provincia De Cordoba
Argentina	Instituto Medico	San Juan	Provincia De San Juan
Argentina	Instituto Medico	San Miguel De Tucumán	Tucuman

Sponsors (1)

Lead Sponsor	Collaborator
Biocodex

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary	Time frame in hours up to the time of the last liquid or loose stoll (defined as type 6 or 7 on Bristol Stool Scale) followed by the first 24-hour period with stool consistency improvement (no liquid or loose stool), i.e. cessation of diarrhea as recorded by the parents in the stool diary.	5 days