NCT05607056

Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 565 (actual)
• Sponsor: Neopharm Bulgaria Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Antibiotic-associated Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sinquanon	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.
DIETARY_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2022-11-27
• Primary completion: 2023-03-20
• Completion: 2023-04-25
• First posted: 2022-11-07
• Last updated: 2024-10-21

Locations

3 sites across 1 country: Bulgaria