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Completed

NCT Number: NCT02169817

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

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).

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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

04, Pilar, Buenos Aires, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Bacillus clausii

Drug

Pharmaceutical form:aqueous suspension Route of administration: oral

Other names: Enterogermina

Oral Rehydration Therapy

Drug

Pharmaceutical form:vials/sachets for solution Route of administration: oral

Other names: Enterolyte

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: cadiLAc

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2014
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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