S. Boulardii in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adults With Respirat… (NCT05261152) | Clinical Trial Compass
CompletedPhase 4
S. Boulardii in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adults With Respiratory Tract Infections
Serbia96 participantsStarted 2017-11-01
Plain-language summary
Antibiotic-associated diarrhea (AAD) is the most common gastrointestinal complication of antibiotic use, with potentially serious clinical impact. The aim of this study is to assess the efficacy and safety of Saccharomyces boulardii in the prevention of AAD in adult patients with lower respiratory tract infection (LRTI) treated in a hospital.
A multicenter, randomized, parallel-group, double-blind, placebo-controlled study is conducted whereby adults who are hospitalized due to LRTI and treated with intravenous antibiotics and randomized to capsules containing S. boulardii or indistinguishable placebo. The outcome measures were: relevant clinical features, gastrointestinal symptoms, and adverse events.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subjects age ≥65 years.
* Informed consent (IC) obtained and signed prior to study participation
* For female subjects: proof of being at least 1 year post-menopausal
* Expected minimum hospital stay of 5 days
* Requiring ≥5 day course of intravenous (IV) antibiotic
* Diagnosis of lower respiratory tract infection (LRTI)
* The subject is willing and able to comply with all testing and study requirements as defined in the protocol.
Exclusion Criteria:
* Active diarrhea (where diarrhea is defined as 3 or more unformed/liquid stools on day prior to randomization)
* Subjects with diarrhea in past 2 weeks
* Current treatment for CDAD or ongoing active CDAD infection, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes) of C. difficile in the stool
* Number of previous CDAD episodes \>1
* Any previously documented CDI within 8 weeks prior to randomization
* Use of broad spectrum antibiotics within 2 months of start of study drug. Antibiotics including those not specified in this protocol for the treatment of the current CAP episode are allowed within 24 h of start of study drug and the protocol-defined treatment for CAP.
* Current treatment with non-beta lactam antibiotics other than macrolides
* Risk of death within 90 days of study entry according to the clinical judgment of the investigator
* Known intolerance of study drug/ingredients
* History of or active, non-controlled infl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.