ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children

Last updated: January 20, 2009
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Gastroenteritis

Colic

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT00457353
ENTER_L_01486
  • Ages 6-5
  • All Genders

Study Summary

Primary:

  • To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children

Secondary:

  • To evaluate the safety of Enterogermina® in acute diarrhea in Indian children

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hoursduration

Exclusion

Exclusion Criteria:

  • History of presence of blood, pus, or mucus in stools

  • Severe dehydration (World Health Organization criteria)

  • Severely malnourished patients

  • Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeksbefore enrolment

  • History of conditions known to producing immunodeficiency (Acquired Immune DeficiencySyndrome, other congenital immunodeficiency syndrome, drug therapy with steroids,anticancer drugs etc)

  • Known hypersensitivity to Bacillus clausii or other probiotics. The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.

Study Design

Total Participants: 264
Study Start date:
March 01, 2007
Estimated Completion Date:

Connect with a study center

  • Sanofi-Aventis

    Mumbai,
    India

    Site Not Available

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