Antibiotic associated diarrhea (AAD) in children MedDRA version: 21.0 Level: PT Classification code 10064065 Term: Prophylaxis against diarrhoea System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Enterogermina/Normaflore Extra
Product Name: Enterogermina/Normaflore Extra
Product Code: SSR29263
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Bacillus clausii
Current Spons
Sponsors
Sanofi Aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children must be 3 months to 5 years of age inclusive, at the time of signing the informed consent. Children who have to start a short-term (3 to 10 days) treatment with oral antibiotics (broad spectrum beta-lactam AB [amoxicillin-with or without clavulanic acid-, or second and third generation of cephalosporines], or macrolides [erythromycin, clarithromycin, roxithromycin and azithromycin]) Participant’s legally authorized representative capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 660 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Chronic or acute diarrheal disease at the time of enrollment in the study. Immunodeficient children or children under immunosuppressive treatment. Children requiring hospitalization. Chronic GI problems (e.g., short gut syndrome, inflammatory bowel disease, gastroesophageal reflux). Severely malnourished participants (children will be considered as severely malnourished if below 70% of the expected weight for age). Chronic diseases of endocrine, cardiovascular, renal or respiratory system or any other clinically significant condition that can jeopardize participant’s condition or study outcomes as judged by the Investigator. Treatment with probiotics or prebiotics within a period of 2 weeks before enrollment. Use of laxatives within one week before enrollment in the study. Oral or intravenous antibiotic treatment within 4 weeks before enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Bacillus clausii versus placebo in prevention of AAD in children in an outpatient setting;Secondary Objective: To evaluate the efficacy of Bacillus clausii versus placebo on prevention of abdominal signs/symptoms (other than diarrhea) associated with antibiotics such as abdominal swelling (belly tension), and vomiting To evaluate the efficacy of Bacillus clausii versus placebo on prevention of infectious diarrhea (diagnosis based on positive tests) To evaluate the efficacy of Bacillus clausii versus placebo on prevention of hospitalization to manage diarrhea, or prevention of (intravenous) rehydration To evaluate the safety of Bacillus clausii.;Primary end point(s): Antibiotic Associated Diarrhea occurrence - Percentage of patients with Antibiotic Associated Diarrhea;Timepoint(s) of evaluation of this end point: From Randomization up to 2 weeks after the end of antibiotic therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Abdominal signs/symptoms - Percentage of participant with any of the abdominal signs/symptoms Abdominal swelling (belly tension) - Percentage of participants with abdominal swelling (belly tension) Vomiting - Percentage of participants with vomiting Infectious diarrhea - Percentage of patients with Infectious diarrhea Hospitalization to manage diarrhea or (intravenous) rehydration - Percentage of participant with hospitalization to manage diarrhea or (intravenous) rehydration. Adverse events - Percentage of participants with adverse events ;Timepoint(s) of evaluation of this end point: From Randomization up to 2 weeks after the end of antibiotic therapy for all secondary endpoints. | — |
Countries
Hungary, Turkey
Outcome results
None listed