Ginger and the Microbiota-gut-brain Connection in Sciatic Pain Individuals
Leslie Shen
Summary
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).
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * 18-85 years old men and women with BMI \< 25 or ≥ 30 kg/m2 * low back or gluteal pain radiating into leg(s) past the knee (sciatica) with pain duration of at least 3 months (chronic sciatica) * pain scale \> 3 out of 10 (0=no pain,10=worst pain imaginable) during the past 24 hours * willingness to accept randomization. * woman of childbearing potential agrees to use an effective form of contraception during the study Exclusion criteria: Sciatica aspects: * known or suspected serious spinal pathology (e.g., cauda equina syndrome or spinal fracture) * scheduled, or bein…
Interventions
- Dietary SupplementPlacebo
Placebo (Sabinsa)
- DrugGinger
Ginger root extract
Locations (2)
- Texas Tech University Health Sciences CenterLubbock, Texas
- Texas Tech University Health Sciences CenterLubbock, Texas