Antibiotics
Conditions
Brief summary
The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.
Interventions
OTHERProbiotic
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. ICF signature; 2. The subject must agree to follow the instructions and to perform study procedures and visits; 3. Male and female subjects between 18 and 65 years old; 4. Subjects who have scheduled a treatment or started the use of antibiotics over 24 hours ago:
Exclusion criteria
1. Generalized infection or bacteremia; 2. Chronic gastrointestinal diseases (e.g., Crohn's Disease and Irritable Bowel Syndrome); 3. Documented chronic diarrhea; 4. Acute diarrhea episode within 24 hours prior to the start of antibiotic use. Use of tube feeding (nasogastric and nasoenteral); 5. Immunodeficiency (radiotherapy or chemotherapy); 6. Use of food with probiotic properties in the last 10 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of diarrhea in subjects using antibiotics | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of diarrhea by severity | — |
Countries
Brazil
Outcome results
None listed