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

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.

Conditions

• Antibiotic-associated Diarrhea

Interventions

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.

Sponsors & Collaborators

• Neopharm Bulgaria Ltd.

  lead INDUSTRY

Principal Investigators

• Georgi Momekov, Prof PhD · Department of Pharmacology, Pharmacotherapy and Toxicology, Medical University of Sofia

• Karen Dzhambazov, Prof, PhD · University hospital for active treatment Sveti Georgi, Medical University-Plovdiv

• Nikolay Sapundziev, Prof, PhD · Department of Neurosurgery and Otorhinolaryngology, Medical University - Varna

• Milena Encheva, MD, PhD · Military Medical Academy, Bulgaria

• Boris Bogov, Prof, PhD · UMHAT "Sveta Anna"

• Rosen Nikolov, Prof, MD · UMHAT St Ivan Rilski

• Rumen Benchev, Prof · Hill Clinic

• Vladimir Hodzhev, Prof, PhD · University Hospital "St George"

• Spiridon Todorov, Prof, PhD · University Hospital "Tsaritsa Yoanna - ISUL"

• Vania Youroukova, Prof, PhD · University Hospital for Pulmonary Diseases " St. Sofia"

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-27

Primary Completion

2023-03-20

Completion

2023-04-25

Countries

• Bulgaria

Study Locations