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

NCT05974657 | Completed

• 1 other identifier: WK2023001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Antibiotic Side Effect; Probiotics; Diarrhea

Keywords

diarrhea; probiotics; Antibiotic Side Effect

Outcome Measures

Primary Outcomes (1)

• Diarrhea Onset Time

  Evaluate stool characteristics on the Bristol Scale (Degree 5-7 indicative of diarrhea).

  14 days

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Composition: 400mg maltodextrin (excipient)； Capsule total weight: 400mg； Primary conditioning: HPMC Capsules (Hydroxypropyl Methylcellulose)； Secondary conditioning：Cardboard case Secondary packaging content：14 capsules / blister, 1 blisters per case Dosage regimen: Take one capsule daily before meals； Storage：Store in a cool, dry place without exposure to the sun.

Other: Probiotic Lactobacillus acidophilus LA85

Probiotic group

ACTIVE COMPARATOR

Composition: 20mg (2x109 UFC/ capsule) Lactobacillus acidophilus LA85 (active principle) and 380mg maltodextrin (excipient)； Capsule total weight: 400mg； Primary conditioning: HPMC Capsules (Hydroxypropyl Methylcellulose)； Secondary conditioning：Cardboard case Secondary packaging content：14 capsules / blister, 1 blisters per case Dosage regimen: Take one capsule daily before meals； Storage：Store in a cool, dry place without exposure to the sun.

Other: Probiotic Lactobacillus acidophilus LA85

Interventions

Probiotic Lactobacillus acidophilus LA85 OTHER

Through a randomized double-blind placebo-controlled method, the patients were randomly divided into placebo group and probiotic intervention group, and took probiotics once a day for 14 consecutive days.

Placebo group; Probiotic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead
• Methodex: collaborator

Study Sites (1)

Ciurana Clinic

Barcelona, Castelldefels, 08860, Spain

Location

Related Publications (1)

• Zhu J, Sun Y, Dong Y, Zhao Y, Gai Z, Fang S. Efficacy and Safety of Lactobacillus acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea: A Randomized, Placebo-Controlled Study. Food Sci Nutr. 2025 Jun 20;13(6):e70490. doi: 10.1002/fsn3.70490. eCollection 2025 Jun.

  PMID: 40548185 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Ciurana, Dr.

  Dentist Ciurana Clinic

  PRINCIPAL INVESTIGATOR

• Xavier Calvo, Dr.

  Dentist Rob Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 3, 2023
• Study Start: August 31, 2021
• Primary Completion: August 3, 2022
• Study Completion: September 13, 2022
• Last Updated: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)