Influence of Ginger Root Extract Supplementation on the Microbiota-Gut-Brain Axis in Individuals with Sciatica: Study Protocol for a Double-Blind, Placebo-Controlled Randomized Trial

Mar 14, 2026Clinical nutrition ESPEN

Ginger Root Supplement Effects on Gut Bacteria and Brain Communication in People with Sciatica

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Abstract

Eighty participants with chronic sciatica will receive either 2,000 mg/day of ginger root extract or a placebo for eight weeks.

Neuropathic pain is linked to damage in the nervous system and can result in complex sensory and emotional symptoms.
Current treatments for neuropathic pain are limited, with opioids posing risks of severe side effects and potential abuse.
The study aims to evaluate the effects of ginger root extract on pain and brain neuroplasticity through the microbiome-gut-brain axis.
Primary outcomes will measure pain and brain connectivity using advanced imaging techniques like resting state-fMRI and Diffusion Tensor Imaging.
Secondary outcomes will assess gut health, including microbiota composition, intestinal permeability, and neuroinflammation.

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Neuropathic pain (NP) is caused by damage to the peripheral or central nervous system and is associated with adverse complex sensory and affective symptoms. There are few current treatment options for NP, and opioid analgesics have severe side effects which can lead to opioid abuse. Therefore, the development of innovative, effective, and safe alternatives is urgently needed. This study will assess the effects of ginger root extract's anti-inflammatory and anti-oxidant properties on individuals with sciatica via the microbiome-gut-brain axis. Eighty participants (18-85 years) with chronic sciatica, classified as lean (n=40, BMI <25 kg/m) or obese (n=40, BMI ≥30 kg/m), will be stratified by age, sex, and BMI to receive 2,000 mg/day of ginger extract or placebo for eight weeks. Primary outcomes are pain-associated outcomes and brain neuroplasticity by assessing functional (resting state-fMRI) and structural (Diffusion Tensor Imaging) connectivity. Secondary outcomes include gut function (gut microbiota composition using 16S rRNA sequencing analysis, intestinal permeability assessing concentrations of plasma lipopolysaccharide binding protein and fecal zonulin, and fecal metabolites using LC-MS/MS analysis) and neuroinflammation: nCounter® Neuroinflammation Panel analysis. We will evaluate outcomes at baseline and end of study. We will employ intention-to-treat principle and per-protocol for data analysis. Hierarchical linear modeling is utilized to estimate ginger supplementation's effects while properly accounting for data dependency and identified covariates. This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center, Lubbock, TX. Participants will sign an informed consent form before enrolling in the study. Our team will actively disseminate the results from this trial through academic conference presentations and peer-reviewed journals. We are now actively recruiting subjects for this study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06817018. 2 2

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Influence of Ginger Root Extract Supplementation on the Microbiota-Gut-Brain Axis in Individuals with Sciatica: Study Protocol for a Double-Blind, Placebo-Controlled Randomized Trial

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