Acceptability and Adherence to Different Dosing Regimens of the Multistrain Probiotic Vivomixx Neo® 460 in Adults Receiving Antibiotic Therapy: a Randomized, Open-label Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adherence to the probiotic using a daily Compliance Form
研究概览
简要总结
This open-label interventional study aims to evaluate the acceptability and adherence of adult participants to the multistrain probiotic Vivomixx Neo® 460 when administered concurrently with antibiotic therapy. Participants are randomized to receive one of two dosing regimens: a low daily dose or a high daily dose. The study will assess the effects of these regimens on the prevention of antibiotic-associated diarrhea (AAD), gastrointestinal symptoms, and patient adherence and acceptability. The results are intended to provide evidence to optimize the clinical use of probiotics alongside antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years
- •Initiation of oral antibiotic therapy lasting more than 3 days
- •History of diarrhea during previous antibiotic treatment
- •Eligible antibiotics include: (a) amoxicillin with clavulanic acid, (b) clindamycin, and (c) second- or third-generation cephalosporins
- •Willingness to provide informed consent to participate in the study
排除标准
- •Pregnancy or breastfeeding
- •Age under 18 years
- •Diagnosis of a chronic autoimmune disease (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis)
- •Diagnosis of type I or type II diabetes
- •Renal or hepatic disease
- •Current use of immunosuppressive medications
- •Current use of other supplements, probiotics, prebiotics, or synbiotics
- •Use of antibiotics within the past month
- •Use of laxatives or antidiarrheal medications within the past 2 weeks
- •Pre-existing diarrhea within the past 2 weeks
- •Self-reported allergy to any component of the probiotic
- •Psychological conditions affecting the ability to provide informed consent (e.g., dementia, psychosis, substance use)
- •Gastrointestinal surgery within the past 6 months
研究组 & 干预措施
One sachet of the probiotic daily
Twenty participants will receive one sachet of the probiotic daily.
干预措施: One sachet of the probiotic daily (Dietary Supplement)
Two sachets of the probiotic daily
Twenty participants will receive two sachets of the probiotic daily.
干预措施: Two sachets of the probiotic daily (Dietary Supplement)
结局指标
主要结局
Adherence to the probiotic using a daily Compliance Form
时间窗: From enrollment to the end of treatment at 17 days maximum
Adherence will be assessed by recording the number of days participants took the supplement and the amount consumed, as well as by considering participant drop-out rates. Methods of measurement * Participants will be required to complete a daily Compliance Form. To minimize potential non-compliance with form completion, weekly telephone follow-up will be conducted. * The number of participants who complete the study and those who withdraw will be recorded. * When available, reasons for withdrawal will be analyzed to better understand participant responses to the intervention.
Acceptability of the probiotic supplement using an acceptability questionnaire
时间窗: 2 weeks (immediately after completion of the 2-week intervention)
Acceptability will be assessed by evaluating participants' perceptions of the intervention procedures and the administered supplement in terms of ease of use, palatability, safety, and compatibility with daily life. Acceptability will be measured using a structured acceptability questionnaire completed at the end of the intervention. The questionnaire will include items assessing ease of intake, difficulties in integrating the supplement into daily routines, perceived safety, overall study experience, and intention to continue product use. Responses will be recorded using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), allowing quantitative analysis.
Daily assessment of stool type using the Bristol Stool Form Scale
时间窗: From enrollment to the end of treatment at 17 days maximum
Changes in bowel habits will be assessed by daily recording of bowel movements throughout the intervention period. Participants will document the frequency of bowel movements and stool type using the Bristol Stool Form Scale. Numbers 6,7 in the Bristol Stool Form are associated with diarrhea.
次要结局
- Effect of the probiotic on fatigue levels(Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention))
- Effect of the intervention on participants' self-reported quality of life by WHOQOL-BREF questionnaire(Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention))
- Effect of the intervention on participants' self-reported quality of life by EQ-5D-5L questionnaire(Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention))
研究者
Vaios Svolos
Dietitian, Postdoctoral Researcher
University of Thessaly