Status:
COMPLETED
Effectiveness and Safety of Lactobacillus Acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Collaborating Sponsors:
Methodex
Conditions:
Antibiotic Side Effect
Probiotics
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This randomized, placebo-controlled, double-blind clinical trial aims to evaluate the efficacy and safety of probiotics as food supplements in preventing antibiotic-associated diarrhea. The study will...
Detailed Description
This randomized, placebo-controlled, double-blind clinical trial aims to assess the effectiveness and safety of probiotics as food supplements in preventing antibiotic-associated diarrhea. The study w...
Eligibility Criteria
Inclusion
- Patients starting antibiotic treatment (Amoxicillin 750mg).
- Patients prone to diarrhea with the administration of Amoxicillin 750mg.
- Patients over 18 years of age.
- Patients of both sexes.
- Patients capable of understanding the clinical study and who are committed to complying with the requirements and procedures of the study.
- Patients who have signed the informed consent.
Exclusion
- Diabetic patients.
- Pregnant patients.
- Patients who are breastfeeding.
- Patients who require pharmacological treatment that triggers drug diarrhea (laxatives, antacids with magnesium, chemotherapy, omeprazole, esomeprazole, lansoprazole, rabeprazole, cimetidine ranitidine, mycophenolate nizatidine, ibuprofen, naproxen and metformin).
- Patients requiring treatment with tricyclic antidepressants, antiepileptics, antihistamines, antiparkinsons, antipsychotics, antispasmodics, verapamil, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium), non-steroidal antidiarrheals and anti-inflammatory drugs.
- Patients who change the type of diet during the study.
- Patients with an allergy or intolerance to any of the ingredients in the formulation of the product under study.
- Subjects with a history of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study.
- Subjects whose condition does not make them eligible for the study, according to the investigator.
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05974657
Start Date
August 31 2021
End Date
September 13 2022
Last Update
August 3 2023
Active Locations (1)
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1
Ciurana Clinic
Barcelona, Castelldefels, Spain, 08860