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Completed

NCT Number: NCT03539913

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

* 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.

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Key information

Conditions

Acute Gastroenteritis

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Medico, Río Cuarto, Córdoba Province, Argentina

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Probiotic : Saccharomyces boulardii

Biological

Treatment for 5 days

Probiotic : Bacillus clausii

Biological

Treatment for 5 days

Primary outcomes

  1. Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biocodex

Industry

Registry information

Acronym: SABINA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 30, 2018
Registry last updated
Jan 22, 2019

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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