Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children (cadiLAc)

Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)

Primary Objective:

To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children.

Secondary Objectives:

To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes.

To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).

Study Overview

• Status: Completed
• Conditions: Acute Gastroenteritis
• Intervention / Treatment: Drug: Bacillus clausii; Drug: Oral Rehydration Therapy

Detailed Description

The maximum duration of study participation for each patient can be 10 days.

• Study Type: Interventional
• Enrollment (Actual): 629
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Mar del Plata, Argentina
    • 01
  • San Miguel de Tucuman, Argentina
    • 06
  • Buenos Aires
    • Pilar, Buenos Aires, Argentina
      • 04
• Brazil
  • Curitiba, Brazil
    • 076002
  • Porto Alegre, Brazil
    • 076006
  • Salvador, Brazil
    • 076003
  • Sao Paulo, Brazil
    • 076001
• Colombia
  • Armenia, Colombia
    • 170002
• Mexico
  • Mexico city, Mexico
    • 484010
• Peru
  • Lima, Peru
    • 604001
  • Lima, Peru
    • 604003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

Infants or children with acute community-acquired diarrhea (≥3 liquid or watery stools occurring in a 24-hour period):

• with less than 48 hours duration
• aged between 6 months and 5 years of age
• whose parents or legal guardians have given their written informed consent
• with clinical indication for ORT per formula of World Health Organization

Exclusion criteria:

Infants or children with:

• presence of blood, pus, or mucus in stools
• severe dehydration
• untreatable vomiting
• antibiotics indication for the treatment of this acute diarrhea;
• hospitalization
• expected hospitalization for the next hours due to the poor clinical conditions
• treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the study is permitted)
• previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents
• indication of any other ORT different from the one prescribed in the study
• chronic diseases including chronic diarrhea
• immunodeficiency (acquired or congenital immunodeficiency)
• other infectious comorbid conditions
• known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics
• parent/legal guardian who, in the opinion of the Investigator, is unable to complete the patient diary or bring the child for the follow-up visit
• participation in another clinical trial in the last 3 months prior to the start of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enterogermina + Enterolyte; 2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation	Drug: Bacillus clausii; Pharmaceutical form:aqueous suspension Route of administration: oral; Other Names: Enterogermina; Drug: Oral Rehydration Therapy; Pharmaceutical form:vials/sachets for solution Route of administration: oral; Other Names: Enterolyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary	from Day 1 to Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean number of stools per day	Day 1 to Day 5
Effect on consistency of stool	Day 1 to Day 5
Number of vomiting episodes per day	Day 1 to Day 5
Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina	Day 1 to Day 5
Parent / Legal guardian's assessment of children's overall general state	Day 1 to Day 5
Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator	Day 1 to Day 5

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Diarrhea; Gastroenteritis
• Other Study ID Numbers: ENTERR06929; U1111-1149-1704 (Other Identifier: UTN)