Clinical trial NCT06817018: Ginger Root Extract for Sciatic Pain Individuals
Official title: Ginger and the Microbiota-gut-brain Connection in Sciatic Pain Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Neuropathic Pain
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 18-85 years old
* low back or gluteal pain radiating into leg(s) past the knee (sciatica) with pain duration of at least 3 months (chronic sciatica)
* visual analog 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 being considered, for spinal surgery or interventional procedures for sciatica during study period
* focal neurological deficits with progressive or disabling symptoms
* low back pain without sciatica

GI aspects:

* history of chronic GI disorder (i.e., irritable bowel syndrome, functional chronic constipation, coeliac diseases)
* history of chronic or systemic autoimmune diseases with GI involvement
* recent (\<1 month) appearance of diarrhea or hematochezia before study begins
* recent (\<1 month) exposure to antibiotics before study starts

Other exclusion considerations:

* pregnant or breast-feeding women
* women of child-bearing potential will have a urine pregnancy test done prior to the baseline MRI and administration of any study drug. If the test is positive, they will be withdrawn from study participation
* cognitive impairment, history of psychiatric conditions indicating mental health instability or incapacity
* likeliness of moving during the trial, lack of transportation, or unavailability at sample collection times.
* presence of a bleeding diathesis
* taking a medication that affects coagulation or platelet function
* unable or unwilling to have study MRIs done
* participants with clinically significant laboratory abnormities of liver function (AST and ALT) and kidney function (BUN and serum creatinine) abnormities

Primary outcomes:
measure: plasma lipopolysaccharide binding protein (LBP)
timeFrame: baseline and after 8 weeks
measure: fecal zonulin
timeFrame: baseline and after 8 weeks
measure: brief pain inventory (BPI)
timeFrame: baseline and after 8 weeks
measure: SF-MPQ
timeFrame: baseline and after 8 weeks
Secondary outcomes:
measure: fecal metabolites using LC-MS/MS analysis
timeFrame: baseline and after 8 weeks
measure: gut microbiome using 16S rRNA amplicon sequencing
timeFrame: baseline and after 8 weeks
measure: neuroinflammation genes
timeFrame: baseline and after 8 weeks
measure: structural connectivity using resting state-fMRI
timeFrame: baseline and after 8 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References:
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