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CompletedNCT05974657Updated Aug 3, 2023

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

An interventional study of Probiotic Lactobacillus acidophilus LA85 in Antibiotic Side Effect, Probiotics and Diarrhea, sponsored by Wecare Probiotics Co., Ltd.. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Aug 2021, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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 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. Duration of diarrhea, if it occurs.
  3. Evaluation of gastrointestinal quality of life using the GIQLI questionnaire.
  4. Overall patient satisfaction with the intervention. Throughout the trial, a double-blind approach will be maintained, ensuring that both the participants and the investigators are unaware of the treatment assignments. This helps minimize bias and ensures the reliability of the results. To assess the efficacy and safety of probiotics, data will be collected and analyzed using appropriate statistical methods. The number of days until the onset of diarrhea will be compared between the two groups, as well as the duration of diarrhea if it occurs. Gastrointestinal quality of life will be evaluated using the GIQLI questionnaire, which measures various aspects related to gastrointestinal well-being. Additionally, overall patient satisfaction with the intervention will be assessed. By conducting this comprehensive clinical trial, we aim to provide valuable insights into the potential benefits and safety of probiotics as food supplements in preventing antibiotic-associated diarrhea. The results obtained will contribute to evidence-based recommendations for healthcare professionals and may have implications for improving patient outcomes and quality of life.
02

Conditions studied

  • Antibiotic Side Effect
  • Probiotics
  • Diarrhea

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Keywords

  • diarrhea
  • probiotics
  • Antibiotic Side Effect
03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 82 is below the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
82 participants (actual)

Study arms

  • Placebo comparator
    Placebo group

    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

  • Active comparator
    Probiotic group

    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

  • OtherProbiotic Lactobacillus acidophilus LA85

    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.

06

What researchers measure

Primary outcomes

  1. Diarrhea Onset Time

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

    Time frame: 14 days

07

Study locations

1 site
  • Ciurana Clinic
    Barcelona, Castelldefels 08860, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05974657
Lead sponsor
Wecare Probiotics Co., Ltd.
Collaborators
Methodex
Responsible party
Sponsor
First posted
Aug 3, 2023
Start date
Aug 31, 2021
Primary completion
Aug 3, 2022
Completion
Sep 13, 2022
Last update
Aug 3, 2023

Study contacts

Joan Ciurana, Dr.
principal investigator · Dentist Ciurana Clinic
Xavier Calvo, Dr.
principal investigator · Dentist Rob Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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