The Multistrain Probiotic OMNi-BiOTiC® Hetox for Treatment After Neurosurgery (ProSURG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change from baseline in Oswestry Disability Index (ODI) at 3 months
研究概览
简要总结
The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Hetox on improving the healing, pain management, and postsurgical complications after neurosurgery.
The main question it aims to answer is:
• Is the multistrain probiotic OMNi-BiOTiC® Hetox effective in in improving patient-reported disability after neurosurgery?
Researchers will compare the probiotic group and the placebo group to determine if the healing is significantly different between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults with MRI-confirmed disc herniation, stenosis, or instability of the lumbar or cervical spine.
- •Able to provide written informed consent
- •Willing to comply with study procedures and follow-up assessments
- •No contraindications to probiotic administration
排除标准
- •symptoms of acute infection (vomiting, fever above 38°C, diarrhea, respiratory symptoms),
- •chronic diseases,
- •use of probiotics one month before inclusion.
结局指标
主要结局
Change from baseline in Oswestry Disability Index (ODI) at 3 months
时间窗: 4 weeks supplementation
Functional disability will be assessed using the Oswestry Disability Index (ODI, version 2.1a; range 0-100, higher = greater disability). The primary outcome is the mean change in ODI from baseline to 3 months post-neurosurgery.
次要结局
未报告次要终点
研究者
Sabina Fijan
Full prof. dr.
University Maribor