Antibiotic-associated DiarrheaSPAADANCT05607056
Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults
A study testing Sinquanon in people with Antibiotic-associated Diarrhea, run by Neopharm Bulgaria Ltd. at 3 sites in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Sinquanon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 565 participants
- Where
- 3 sitesBulgaria
- Study dates
- 27 Nov 2022to 25 Apr 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subject aged 18 to 60 years.
- 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
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- 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.
Who cannot join
- Antibiotics use within 60 days prior to randomization.
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Bulgaria3 sites
University Hospital "St George"
Plovdiv, 4002
University Hospital for Pulmonary Diseases " St. Sofia"
Sofia, 1431
University Hospital "Tsaritsa Yoanna - ISUL"
Sofia, 1527
About this study
Official title: 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
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.
Read the 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
- Being tested
- Sinquanon, Placebo
- Keywords
- Probiotics, Antibiotics, Antibiotic-associated diarrhea, High-dose, Multistrain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinquanonDietary supplement
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 supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 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. Receives: Dietary Supplement: Sinquanon |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: By 21+2 days after completion of antibiotic dosing.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: By 21+2 days after completion of antibiotic dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start27 Nov 2022
- Primary completion20 Mar 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neopharm Bulgaria Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georgi Momekov, Prof PhD, Principal investigator, Department of Pharmacology, Pharmacotherapy and Toxicology, Medical University of SofiaKaren Dzhambazov, Prof, PhD, Principal investigator, University hospital for active treatment Sveti Georgi, Medical University-PlovdivNikolay Sapundziev, Prof, PhD, Principal investigator, Department of Neurosurgery and Otorhinolaryngology, Medical University - VarnaMilena Encheva, MD, PhD, Principal investigator, Military Medical Academy, BulgariaBoris Bogov, Prof, PhD, Principal investigator, UMHAT "Sveta Anna"Rosen Nikolov, Prof, MD, Principal investigator, UMHAT St Ivan RilskiRumen Benchev, Prof, Principal investigator, Hill ClinicVladimir Hodzhev, Prof, PhD, Principal investigator, University Hospital "St George"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607056
- Sponsor's protocol ID
- SPAADA202211_001
- Other IDs
- 2022-002817-40
- Acronym
- SPAADA
- Status last verified
- Dec 2022
- First submitted
- 31 Oct 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33207631Francino 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.
PubMed 26793178Mekonnen 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.
PubMed 32087535Barbut 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.
PubMed 12052785Szajewska 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.
PubMed 26365389Szajewska 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.
PubMed 26216624Ouwehand 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.
PubMed 28008787Szajewska 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.
PubMed 26756877Goldenberg 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.
PubMed 26695080Gao 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.
PubMed 20145608Hodzhev 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.
PubMed 39529939