NCT07640152尚未招募不适用
High Fermented Food Intake to Improve Gut Microbiome and Bowel Dysfunction in Individuals With SCI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. The main questions it aims to answer are:
- Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI?
- Does fermented food intake change gut microbiome composition, short-chain fatty acid production, and intestinal inflammation?
Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes.
Participants will:
- Consume study foods daily for 10 weeks
- Attend 2 in-person study visits
- Collect stool samples at home and ship them overnight to the research team using provided collection kits and prepaid shipping materials
- Complete bowel health questionnaires and dietary recalls
- Undergo Sitz marker testing with abdominal X-rays to assess colonic transit
- Participate in biweekly monitoring contacts throughout the study period
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years
- •At least 1 year post-onset of spinal cord injury, consistent with chronic spinal cord injury
- •Traumatic spinal cord injury involving cervical or thoracic levels
- •American Spinal Injury Association Impairment Scale classification A-D
- •Medically stable, with no recent hospitalizations or acute illnesses
- •Able to safely consume study foods, including fermented and control food products
- •Experiencing neurogenic bowel dysfunction, defined by at least one of the following:
- •Three or fewer bowel movements per week
- •More than 60 minutes required per bowel care routine
- •Symptoms of incomplete evacuation
- •Abdominal distension
- •Fecal incontinence
- •Established and stable bowel program, defined as a consistent individualized routine of timing, frequency, and evacuation methods that has remained unchanged for at least 4 weeks before enrollment
排除标准
- •Antibiotic use within the past 4 weeks
- •Active gastrointestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal obstruction
- •Current intake of probiotics or fermented foods exceeding 3 servings per day
- •Pregnancy or breastfeeding
- •Recent major bowel surgery within the past 12 weeks
- •Unresolved fecal impaction
- •Unstable bowel regimen that could interfere with accurate motility assessment
- •Inability to safely undergo Sitz marker testing, including any of the following:
- •Inability to swallow the capsule
- •Pregnancy, due to radiation exposure
- •Contraindication to abdominal X-ray procedures
研究者
Jia Li
Research Scientist
Ohio State University
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Probiotics Supplementation for Neurodevelopment in Preterm InfantsPremature BirthNCT07617181Fudan University116
招募中
不适用
Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel DiseaseIBDNCT07385807University of British Columbia80
招募中
不适用
The Impact of Probiotic Intervention on the Gut Microbiota and Bowel FunctionNCT07369830Huashan Hospital156
尚未招募
不适用
Influence of Probiotics on Early Gut Microbial ColonizationNCT07608341BioGaia AB150
尚未招募
不适用
Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE)NCT07555626TC Erciyes University60
