CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 565 enrolled
Drug / intervention
Sinquanon +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05607056
NCT05607056N/ACompleted

Phase 4, Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults in the Out-patient Setting: Prospective, Multicenter, Double-blind, Placebo-controlled Randomized Parallel-arm Clinical Study

Neopharm Bulgaria Ltd.·interventional·Posted Nov 7, 2022·Updated Oct 21, 2024

In Brief

A clinical study evaluating Sinquanon and Placebo for Antibiotic-associated Diarrhea. Completed, enrolled 565 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 7, 2022
Enrollment StartNov 27, 2022
Primary CompletionMar 20, 2023
Study CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.7 years ago

Interventions

Sinquanondietary

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.

Placebodietary

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.