Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults
NCT ID: NCT05607056
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
565 participants
INTERVENTIONAL
2022-11-27
2023-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Probiotic
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.
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.
Placebo
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 the diarrhea.
* Acute or chronic constipation - average number of formed stools \<3 per week.
* Allergy or hypersensitivity to any of the ingredients of the trial product.
* Allergy or hypersensitivity to the antibiotic prescribed on Day 1.
* Prior documented infection with Clostridioides difficile ≤3 months before screening.
* History of chronic gastrointestinal conditions, including irritable bowel syndrome, chronic constipation, chronic diarrhea, dyspepsia, gastroesophageal reflux disease, diverticulitis, ulcerative colitis, Crohn's disease or any other abnormality in the absorption or gastrointestinal dysfunction.
* Use of proton-pump inhibitors (PPIs) within 30 days prior to Day 1 and for the duration of the study.
* Surgery to the intestines, artificial heart valve, history of rheumatological heart disease or infectious endocarditis within one year prior to screening.
* Immunosuppressive therapy or any condition causing immunosuppression (including hematologic malignancies, AIDS, long-lasting corticosteroid treatment).
* Planned administration of antibiotics, different from those acceptable for the study.
* Patients in severe condition requiring urgent hospitalization or planned hospitalization during the study.
* Planned administration of antibiotics \>10 days.
* BMI ≥ 30 kg/m2.
* Pregnant or lactating women; women who plan to get pregnant during the study.
* Drug abuse or alcohol within the past year.
* Unstable medical conditions, in the judgement of the Investigator.
* Eating disorders (for example, anorexia, bulimia).
* On a vegan diet.
* Participation in a clinical trial within 60 days prior to randomization.
* Inability to comply with the study protocol.
18 Years
60 Years
ALL
No
Sponsors
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Neopharm Bulgaria Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Georgi Momekov, Prof PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Pharmacology, Pharmacotherapy and Toxicology, Medical University of Sofia
Karen Dzhambazov, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
University hospital for active treatment Sveti Georgi, Medical University-Plovdiv
Nikolay Sapundziev, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery and Otorhinolaryngology, Medical University - Varna
Milena Encheva, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Military Medical Academy, Bulgaria
Boris Bogov, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
UMHAT "Sveta Anna"
Rosen Nikolov, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
UMHAT St Ivan Rilski
Rumen Benchev, Prof
Role: PRINCIPAL_INVESTIGATOR
Hill Clinic
Vladimir Hodzhev, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital "St George"
Spiridon Todorov, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital "Tsaritsa Yoanna - ISUL"
Vania Youroukova, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital for Pulmonary Diseases " St. Sofia"
Locations
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University Hospital "St George"
Plovdiv, , Bulgaria
University Hospital for Pulmonary Diseases " St. Sofia"
Sofia, , Bulgaria
University Hospital "Tsaritsa Yoanna - ISUL"
Sofia, , Bulgaria
Countries
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References
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Konstantinidis T, Tsigalou C, Karvelas A, Stavropoulou E, Voidarou C, Bezirtzoglou E. Effects of Antibiotics upon the Gut Microbiome: A Review of the Literature. Biomedicines. 2020 Nov 16;8(11):502. doi: 10.3390/biomedicines8110502.
Francino MP. Antibiotics and the Human Gut Microbiome: Dysbioses and Accumulation of Resistances. Front Microbiol. 2016 Jan 12;6:1543. doi: 10.3389/fmicb.2015.01543. eCollection 2015.
Mekonnen SA, Merenstein D, Fraser CM, Marco ML. Molecular mechanisms of probiotic prevention of antibiotic-associated diarrhea. Curr Opin Biotechnol. 2020 Feb;61:226-234. doi: 10.1016/j.copbio.2020.01.005. Epub 2020 Feb 19.
Barbut F, Meynard JL. Managing antibiotic associated diarrhoea. BMJ. 2002 Jun 8;324(7350):1345-6. doi: 10.1136/bmj.324.7350.1345. No abstract available.
Szajewska H, Kolodziej M. Systematic review with meta-analysis: Lactobacillus rhamnosus GG in the prevention of antibiotic-associated diarrhoea in children and adults. Aliment Pharmacol Ther. 2015 Nov;42(10):1149-57. doi: 10.1111/apt.13404. Epub 2015 Sep 13.
Szajewska H, Kolodziej M. Systematic review with meta-analysis: Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2015 Oct;42(7):793-801. doi: 10.1111/apt.13344. Epub 2015 Jul 27.
Ouwehand AC. A review of dose-responses of probiotics in human studies. Benef Microbes. 2017 Apr 26;8(2):143-151. doi: 10.3920/BM2016.0140. Epub 2016 Dec 23.
Szajewska H, Canani RB, Guarino A, Hojsak I, Indrio F, Kolacek S, Orel R, Shamir R, Vandenplas Y, van Goudoever JB, Weizman Z; ESPGHAN Working Group for ProbioticsPrebiotics. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Children. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):495-506. doi: 10.1097/MPG.0000000000001081.
Goldenberg JZ, Lytvyn L, Steurich J, Parkin P, Mahant S, Johnston BC. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database Syst Rev. 2015 Dec 22;(12):CD004827. doi: 10.1002/14651858.CD004827.pub4.
Gao XW, Mubasher M, Fang CY, Reifer C, Miller LE. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. Am J Gastroenterol. 2010 Jul;105(7):1636-41. doi: 10.1038/ajg.2010.11. Epub 2010 Feb 9.
Hodzhev V, Dzhambazov K, Sapundziev N, Encheva M, Todorov S, Youroukova V, Benchev R, Nikolov R, Bogov B, Momekov G, Hadjiev V. High-dose Probiotic Mix of Lactobacillus spp., Bifidobacterium spp., Bacillus coagulans, and Saccharomyces boulardii to Prevent Antibiotic-associated Diarrhea in Adults: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial (SPAADA). Open Forum Infect Dis. 2024 Oct 21;11(11):ofae615. doi: 10.1093/ofid/ofae615. eCollection 2024 Nov.
Other Identifiers
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2022-002817-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPAADA202211_001
Identifier Type: -
Identifier Source: org_study_id
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