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

Primary Purpose

Acute Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Bacillus clausii
Oral Rehydration Therapy
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gastroenteritis

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 04
  • 01
  • 06
  • 076002
  • 076006
  • 076003
  • 076001
  • 170002
  • 484010
  • 604001
  • 604003

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enterogermina + Enterolyte

Arm Description

2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2014
Last Updated
January 20, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02169817
Brief Title
Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children
Acronym
cadiLAc
Official Title
Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
The maximum duration of study participation for each patient can be 10 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
629 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enterogermina + Enterolyte
Arm Type
Experimental
Arm Description
2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation
Intervention Type
Drug
Intervention Name(s)
Bacillus clausii
Other Intervention Name(s)
Enterogermina
Intervention Description
Pharmaceutical form:aqueous suspension Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Oral Rehydration Therapy
Other Intervention Name(s)
Enterolyte
Intervention Description
Pharmaceutical form:vials/sachets for solution Route of administration: oral
Primary Outcome Measure Information:
Title
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
Time Frame
from Day 1 to Day 5
Secondary Outcome Measure Information:
Title
Mean number of stools per day
Time Frame
Day 1 to Day 5
Title
Effect on consistency of stool
Time Frame
Day 1 to Day 5
Title
Number of vomiting episodes per day
Time Frame
Day 1 to Day 5
Title
Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina
Time Frame
Day 1 to Day 5
Title
Parent / Legal guardian's assessment of children's overall general state
Time Frame
Day 1 to Day 5
Title
Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator
Time Frame
Day 1 to Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
04
City
Pilar
State/Province
Buenos Aires
Country
Argentina
Facility Name
01
City
Mar del Plata
Country
Argentina
Facility Name
06
City
San Miguel de Tucuman
Country
Argentina
Facility Name
076002
City
Curitiba
Country
Brazil
Facility Name
076006
City
Porto Alegre
Country
Brazil
Facility Name
076003
City
Salvador
Country
Brazil
Facility Name
076001
City
Sao Paulo
Country
Brazil
Facility Name
170002
City
Armenia
Country
Colombia
Facility Name
484010
City
Mexico city
Country
Mexico
Facility Name
604001
City
Lima
Country
Peru
Facility Name
604003
City
Lima
Country
Peru

12. IPD Sharing Statement

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Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children

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