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

Phase 4

Completed

• Conditions: Acute Gastroenteritis

• Registration Number: NCT03539913
• Lead Sponsor: Biocodex

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-05-30
• Primary Completion: 2018-06-09
• Study Completion: 2018-06-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary	5 days	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.

Trial Locations

Locations (6)

Instituto Medico; 🇦🇷 San Miguel De Tucumán, Tucuman, Argentina

Consultorio Privado 1; 🇦🇷 Caba, Argentina

Consultorio Privado 4; 🇦🇷 Caba, Argentina

Grupo Pediatrico; 🇦🇷 Caba, Argentina

Consultorio Privado 2; 🇦🇷 Caba, Argentina

Consultario Privado 3; 🇦🇷 Caba, Argentina