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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169817
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

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).


Condition or disease Intervention/treatment Phase
Acute Gastroenteritis Drug: Bacillus clausii Drug: Oral Rehydration Therapy Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 629 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)
Study Start Date : July 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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 Name: Enterogermina

Drug: Oral Rehydration Therapy
Pharmaceutical form:vials/sachets for solution Route of administration: oral
Other Name: Enterolyte




Primary Outcome Measures :
  1. 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 Measures :
  1. Mean number of stools per day [ Time Frame: Day 1 to Day 5 ]
  2. Effect on consistency of stool [ Time Frame: Day 1 to Day 5 ]
  3. Number of vomiting episodes per day [ Time Frame: Day 1 to Day 5 ]
  4. Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina [ Time Frame: Day 1 to Day 5 ]
  5. Parent / Legal guardian's assessment of children's overall general state [ Time Frame: Day 1 to Day 5 ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169817


Locations
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Argentina
04
Pilar, Buenos Aires, Argentina
01
Mar del Plata, Argentina
06
San Miguel de Tucuman, Argentina
Brazil
076002
Curitiba, Brazil
076006
Porto Alegre, Brazil
076003
Salvador, Brazil
076001
Sao Paulo, Brazil
Colombia
170002
Armenia, Colombia
Mexico
484010
Mexico city, Mexico
Peru
604001
Lima, Peru
604003
Lima, Peru
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02169817    
Other Study ID Numbers: ENTERR06929
U1111-1149-1704 ( Other Identifier: UTN )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Gastroenteritis
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases