NCT06870331招募中不适用
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial
Swiss Paraplegic Research, Nottwil2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gastrointestinal symptoms
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of probiotic and prebiotic supplementation in individuals with chronic spinal cord injury experiencing gastrointestinal complaints.
The main questions this trail aims to answer are:
- what are the effects of the supplementation on gastrointestinal symptoms?
- what are the effects of the supplementation on gut microbiome composition?
- what are the effects of the supplementation on inflammatory serum markers?
- what are the effects of the supplementation on gastrointestinal transit time?
Participants will:
- take either the probiotic or prebiotic supplement daily for eight weeks, followed by a four-week "wash-out period" (= no intake of either supplement) and a subsequent eight-week intake of the other supplement.
- visit the study center for four appointments, during which various measurements will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •(at screening):
- •Age: ≥ 18 years
- •Sex: male and female.
- •Chronic SCI (>1 year post-injury)
- •Individuals with para- and tetraplegia (American Spinal Cord Injury (ASIA) Impairment Scale (AIS) score A-D)
- •Having significant gastrointestinal complaints, indicated with "yes" at screening and by a GIQLI questionnaire score below 110 at baseline
- •Signed written informed consent
排除标准
- •(at screening):
- •Antibiotic use within the last four weeks before starting the study
- •Major dietary changes within the last four weeks before starting the study, such as initiating a vegan or ketogenic diet
- •Presence of clinically relevant medical conditions, including Crohn's disease, diagnosed eating or gastrointestinal disorders, assessed on an individual basis
- •Intake of significant concomitant medication, including immunomodulating therapy, mesalazines, or steroids, assessed on an individual basis
- •Concurrent participation in other clinical trials investigating or potentially affecting GI health
- •Insufficient German language skills to follow the study procedures
- •Pregnancy (anamnestic)
研究组 & 干预措施
Prebiotic intervention
Active Comparator
Prebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species.
干预措施: Prebiotic (Dietary Supplement)
Probiotic intervention
Experimental
Probiotics add beneficial bacterial strains to the gut, which can restore microbial balance.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Gastrointestinal symptoms
时间窗: Before and after eight weeks of intake of the dietary supplement.
Change in gastrointestinal symptoms using the Gastrointestinal Quality of Life (GIQLI) questionnaire.
次要结局
- Gut microbiome composition(Before and after eight weeks of intake of the dietary supplement.)
- Inflammatory markers(Before and after eight weeks of intake of the dietary supplement.)
- Gastrointestinal transit time(Before and after eight weeks of intake of the dietary supplement.)
研究者
研究点 (2)
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