An interventional study of Sinquanon and Placebo in Antibiotic-associated Diarrhea, sponsored by Neopharm Bulgaria Ltd.. Completed at 3 sites in Bulgaria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Neopharm Bulgaria Ltd. · Not applicable, Interventional, and Prevention
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.
The study aims to evaluate the efficacy of a specialized multi-strain probiotic, SINQUANON, on the reduction of the incidence of antibiotic-associated diarrhea in adults and to demonstrate the benefit of administering the specialized multi-strain probiotic as a routine add-on to antibiotic therapy on prevention of antibiotic-associated diarrhea in adults who take antibiotics in the outpatient setting.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 565 is above the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Neopharm Bulgaria Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Acceptable antibiotic therapy:
Sequential administration of two antibiotics from the allowed groups is permitted, if the total duration of the antibiotic treatment does not exceed 10 days.
Exclusion Criteria:
During the antibiotic dosing (from 5 to 10 days): 2 capsules once a day 2 hours before or 2 hours after antibiotic administration. 14 days following completion of antibiotic dosing: 1 capsule a day.
Dietary Supplement: Sinquanon
During the antibiotic dosing (from 5 to 10 days): 2 capsules once a day 2 hours before or 2 hours after antibiotic administration. 14 days following completion of antibiotic dosing: 1 capsule a day.
Dietary Supplement: Placebo
This probiotic food supplement includes fourteen probiotic bacterial strains of Lactobacillus Spp, Bifidobacterium Spp., Bacillus coagulans, Saccharomyces boulardii, three prebiotics and Vitamin-B complex - B1, B2, B3, B6, B7, B9 in an enterosolvent cellulose capsule. The product includes supplementary substances: maltodextrin and magnesium stearate. 2 capsules once a day during the antibiotic dosing. 1 capsule a day for 14 days following completion of antibiotic dosing.
The placebo product will have the same appearance as the active product and the same composition but without the live bacteria, prebiotics, and vitamin-B complex. 2 capsules once a day during the antibiotic dosing. 1 capsule a day for 14 days following completion of antibiotic dosing.
Incidence of Antibiotic-Associated diarrhea (AAD)
The incidence of AAD is defined as the number of subjects who experience at least one day of diarrhea compared to the total number of subjects enrolled in the given treatment arm. AAD is defined as 3 or more loose or liquid stools (types 5-7 according to Bristol Stool Scale \[BSS\]) over a period of 24 hours.
Time frame: By 21+2 days after completion of antibiotic dosing.
Severity of AAD
Investigator will assess AAD severity using the following modified scale defining AAD as: severe: ≥7 unformed/loose/liquid stools; moderate: 5-6 unformed/loose/liquid stools; mild: a change in the stool pattern 3-4 unformed/loose/liquid stools a day. Investigator's assessment will take into consideration the 24-hour period presenting with the worst severity.
Time frame: By 21+2 days after completion of antibiotic dosing.
Duration of diarrhea
Number of sequential days with diarrhea. Defined as the time until the first normalization of the stool form according to BSS: presence of one or two sequential normal stools, i.e. "soft and formed" or "hard and formed" - types 1-4 per BSS (or lack of stool) for a period of 24 hours.
Time frame: By 21+2 days after completion of antibiotic dosing.
Antibiotic-associated adverse experiences (abdominal pain, bloating, passing gas, nausea)
Presence of abdominal pain, bloating, passing gass, nausea - Yes/No.
Time frame: By 21+2 days after completion of antibiotic dosing.
Visual-analogue scale for the gastrointestinal quality of life (VAS-QoL)
Measured via Visual-analogue scale for the gastrointestinal quality of life. The subjects will answer the question: "To what extent the abdominal problems impact your quality of life?" This scale has numerical points from 0 to 100. "100" indicates THE WORST quality of life one can imagine, "0" indicates NO problems and THE BEST quality of life one can imagine.
Time frame: By 21+2 days after completion of antibiotic dosing.
Adverse events (AE)
Incidence of mild (for example, self-resolving), moderate (for example, those requiring medical evaluation) and serious AEs (for example, events requiring lasting hospitalization) adverse events.
Time frame: By 21+2 days after completion of antibiotic dosing.
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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