Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults (NCT05607056) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults
Bulgaria565 participantsStarted 2022-11-27
Plain-language summary
The purpose of this study is to evaluate the efficacy of a probiotic, SINQUANON, on the reduction of the occurrence of diarrhea associated with antibiotic use in adults.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Male or female subject aged 18 to 60 years.
* The subject has given written informed consent after being provided orally with information about the study objective and design, including the administration regimen of the studied probiotic and the study procedures, the available safety data, as well as the rights and obligations of a participant.
* The subject initiates oral antibiotic treatment in the ambulatory setting.
* Acceptable antibiotic therapy:
* Broad-spectrum penicillins
* Cephalosporins
* Quinolones
* Tetracyclines
Sequential administration of two antibiotics from the allowed groups is permitted, if the total duration of the antibiotic treatment does not exceed 10 days.
* Planned duration of the antibiotic treatment of 5 to 10 days.
* Body mass index (BMI) of 18.0 to 29.9 kg/m2
* In the opinion of the Investigator, the subject can adhere to the visit schedule, to be compliant with the trial treatment regimen and to complete the study.
* The patient has a smartphone and can use it.
Exclusion Criteria:
* Antibiotics use within 60 days prior to randomization.
* Daily consumption of probiotics, yogurt with probiotics and inability to stop this consumption.
* Use of antidiarrheal medications, laxatives, enemas, or suppositories within 1 week prior to randomization and for the duration of the trial.
* An episode of diarrhea within 30 days before screening, defined as ≥3 loose or liquid stools over 24 hours, regardless of the cause of t…
What they're measuring
1
Incidence of Antibiotic-Associated diarrhea (AAD)
Timeframe: By 21+2 days after completion of antibiotic dosing.