Preventing Antibiotic-Associated Diarrhea Using Erceflora

• Conditions: Diarrhea associated to antibiotics; MedDRA version: 17.1Level: LLTClassification code 10000706Term: Acute diarrheaSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004629-42-Outside-EU/EEA
• Lead Sponsor: Sanofi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-03
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Hospitalised, immunocompetent infants or children

• Aged between 6 months and 12 years old

• Admitted for mild to moderate infection of either the urinary, respiratory and skin and soft tissue

• Whose parents or legal guardian have given their written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 323
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• unstable medical condition
• In any form of immunocompromised state
• With immunosuppressive conditions
• With contraindication to take medications per orem
• Antibiotics use 3 weeks before start of trial
• Presence of diarrhea prior to trial initiation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety of the probiotic Bacillus clausii in preventing antibiotic-associated diarrhea among hospitalized immunocompetent Filipino infant and children.;Secondary Objective: • To assess the efficacy of Bacillus clausii in reducing the incidence of diarrhea events associated with antibiotic therapy compared with the control group.<br>• To assess the effect of Bacillus clausii in reducing the gastrointestinal-related symptoms and the duration of diarrhea days among participants with AAD.<br>• To assess the impact of Bacillus clausii supplementation on the over-all reduction in hospitalization days.<br>• To assess the efficacy in preventing C. difficile associated diarrhea or colitis<br>;Primary end point(s): Number of antibiotic associated diarrhea events;Timepoint(s) of evaluation of this end point: Day 0 - 6 weeks post treatment (max. 9 weeks)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of antibiotic associated diarrhea events per day<br>- Number of gastro-intestinal related symptoms<br>- Number of hospital days<br>- Number of C. difficile diarrhea ;Timepoint(s) of evaluation of this end point: Day 0 - 6 weeks post treatment (max. 9 weeks)