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Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated Diarrhea (ACROSS)

Eurofarma logo

Eurofarma

Status and phase

Withdrawn
Phase 3

Conditions

Antibiotics

Treatments

Other: Probiotic

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The study's objective is to evaluate the efficacy and safety of two formulations for the prophylactic treatment of diarrhea in subjects using antibiotics.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Saccharomyces boulardii capsules (200 mg).
Experimental group
Treatment:
Other: Probiotic
Other: Probiotic
Other: Probiotic
Floratil®
Active Comparator group
Treatment:
Other: Probiotic
Other: Probiotic
Other: Probiotic
Saccharomyces boulardii powder (200 mg).
Experimental group
Treatment:
Other: Probiotic
Other: Probiotic
Other: Probiotic

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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