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临床试验/NCT06817018
NCT06817018招募中2 期

Ginger and the Microbiota-gut-brain Connection in Sciatic Pain Individuals

Leslie Shen1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月1日最近更新:
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
plasma lipopolysaccharide binding protein (LBP)

研究概览

简要总结

Neuropathic pain affects the quality of life of many Americans. Non-pharmacological strategies such as bioactive compounds in foods are being explored as therapeutics but can also serve as tools to better understand pain mechanisms. The previous study reported that ginger root extract supplementation palliated pain-spectrum behaviors in animals with neuropathic pain via the microbiota-gut-brain axis. The proposed study is primarily designed to use ginger supplementation for a better understanding of the role of microbiota-gut-brain interactions in sciatica states in a randomized, double-blinded, and placebo-controlled trial. Eighty participants with sciatica will be randomized to receive placebo (2000 mg starch daily) or ginger (2000 mg daily) for 8 weeks. This study will evaluate the effects of ginger supplementation on gut function measured as gut microbiota composition using 16S rRNA sequencing analysis, intestinal permeability based on plasma lipopolysaccharide binding protein and fecal zonulin using ELISA, and fecal metabolites using LC-MS/MS analysis (SA 1); on neuroinflammation in whole blood mRNA using nCounter® Neuroinflammation Panels analysis (SA 2); and on pain-associated outcomes and brain neuroplasticity by assessing functional (resting state-fMRI) and structural (Diffusion Tensor Imaging) connectivity (SA 3).

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo group: 2,000 mg cellulose daily for 8 weeks

干预措施: Placebo (Dietary Supplement)

Ginger

Active Comparator

Ginger group: 2,000 mg ginger root extract daily for 8 weeks

干预措施: Ginger (Drug)

结局指标

主要结局

plasma lipopolysaccharide binding protein (LBP)

时间窗: baseline and after 8 weeks

Intestinal permeability biomarker

fecal zonulin

时间窗: baseline and after 8 weeks

intestinal permeability marker

brief pain inventory (BPI)

时间窗: baseline and after 8 weeks

pain assessment

SF-MPQ

时间窗: baseline and after 8 weeks

pain assessment

次要结局

  • fecal metabolites using LC-MS/MS analysis(baseline and after 8 weeks)
  • gut microbiome using 16S rRNA amplicon sequencing(baseline and after 8 weeks)
  • neuroinflammation genes(baseline and after 8 weeks)
  • structural connectivity using resting state-fMRI(baseline and after 8 weeks)

研究者

发起方
Leslie Shen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leslie Shen

Professor of Pathology

Texas Tech University Health Sciences Center

研究点 (1)

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