Effectiveness and Safety of Lactobacillus Acidophilus LA85 in Preventing Antibiotic-Associated Di… (NCT05974657) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness and Safety of Lactobacillus Acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea
Spain82 participantsStarted 2021-08-31
Plain-language 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 involve 82 patients who will be randomly assigned to one of two groups: an experimental group receiving a probiotic containing Lactobacillus acidophilus LA85, and a placebo group. The primary outcomes measured include the number of days until the onset of diarrhea, the duration of diarrhea (if it occurs), gastrointestinal quality of life evaluation using the GIQLI questionnaire, and overall patient satisfaction.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.