Effectiveness and Safety of Lactobacillus Acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea

Launched by WECARE PROBIOTICS CO., LTD. · Jul 25, 2023

Keywords

ClinConnect Summary

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 will enroll 82 patients who will be randomly assigned to either the experimental group or the placebo group. Participants in the experimental group will receive a probiotic supplement containing Lactobacillus acidophilus LA85, while those in the placebo group will receive a non-active substitute.

The outcomes include the following measurements:

1. Number of days until the onset of diarrhea.
2....

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.