Antibiotic Side EffectNCT05974657
Effectiveness and Safety of Lactobacillus Acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea
A study testing Probiotic Lactobacillus acidophilus LA85 in people with Antibiotic Side Effect and Probiotics, run by Wecare Probiotics Co., Ltd. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antibiotic Side Effect, Probiotics, Diarrhea
- What is being tested?
- Probiotic Lactobacillus acidophilus LA85
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2021to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactobacillus Acidophilus LA85 for Preventing Antibiotic-Associated Diarrhea: A Multi-Centric, Double-Blind, Randomized Study
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:
- Number of days until the onset of diarrhea.
- Duration of diarrhea, if it occurs.
- Evaluation of gastrointestinal quality of life using the GIQLI questionnaire.
- 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.
- Conditions
- Antibiotic Side Effect, Probiotics, Diarrhea
- Being tested
- Probiotic Lactobacillus acidophilus LA85
- Keywords
- diarrhea, probiotics, Antibiotic Side Effect
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Lactobacillus acidophilus LA85Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Probiotic Lactobacillus acidophilus LA85 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea Onset Time
Evaluate stool characteristics on the Bristol Scale (Degree 5-7 indicative of diarrhea).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start31 Aug 2021
- Primary completion3 Aug 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Side EffectStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Methodex
- Responsible party
- Sponsor
- Investigators
- Joan Ciurana, Dr., Principal investigator, Dentist Ciurana ClinicXavier Calvo, Dr., Principal investigator, Dentist Rob Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974657
- Sponsor's protocol ID
- WK2023001
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40548185
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Acidophilus LA85 for Preventing Antibiotic-Associated Diarrhea: A Multi-Centric, Double-Blind, Randomized Study
- ClinicalTrials.gov ID
- NCT05974657
- Acronym / sponsor ID
- WK2023001
- Conditions
- Antibiotic Side Effect, Probiotics, Diarrhea
- Keywords
- diarrhea, probiotics, Antibiotic Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Methodex
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Number of days until the onset of diarrhea.
- Duration of diarrhea, if it occurs.
- Evaluation of gastrointestinal quality of life using the GIQLI questionnaire.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Probiotic Lactobacillus acidophilus LA85Composition: 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. |
| Probiotic group | Active comparator | Other: Probiotic Lactobacillus acidophilus LA85Composition: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Lactobacillus acidophilus LA85Through 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. | Other | Placebo group, Probiotic group |
Primary outcome
Diarrhea Onset Time
Time frame: 14 days
Evaluate stool characteristics on the Bristol Scale (Degree 5-7 indicative of diarrhea).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 40548185Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Ciurana, Dr. principal investigator
Dentist Ciurana Clinic
Xavier Calvo, Dr. principal investigator
Dentist Rob Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Lactobacillus acidophilus LA85 in people with Antibiotic Side Effect and Probiotics, run by Wecare Probiotics Co., Ltd. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea Onset Time (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.