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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 565
- 试验地点
- 6
- 主要终点
- Incidence of Antibiotic-Associated diarrhea (AAD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigators will be provided with coded and identical products. Each individual involved in the study will be blinded to the assignment until study completion. Considering the established safety profile of the probiotic strains no necessity is foreseen for urgent unblinding of treatment assignment. With this in mind, no copies of the treatment assignments will be stored at the enrollment sites. If needed, the Investigators may receive information about the assignment of a particular subject only after review and approval by the Medical monitor. No information about the subjects will be shared with the company conducting the randomization.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
- •Allergy or hypersensitivity to the antibiotic prescribed on Day
- •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/m
- •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.
结局指标
主要结局
Incidence of Antibiotic-Associated diarrhea (AAD)
时间窗: By 21+2 days after completion of antibiotic dosing.
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.
次要结局
- Duration of diarrhea(By 21+2 days after completion of antibiotic dosing.)
- Antibiotic-associated adverse experiences (abdominal pain, bloating, passing gas, nausea)(By 21+2 days after completion of antibiotic dosing.)
- Adverse events (AE)(By 21+2 days after completion of antibiotic dosing.)
- Visual-analogue scale for the gastrointestinal quality of life (VAS-QoL)(By 21+2 days after completion of antibiotic dosing.)
- Severity of AAD(By 21+2 days after completion of antibiotic dosing.)