Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men and women aged 18 to 85 years old with a body mass index (a measure of body weight relative to height) either below 25 or at 30 or above
• People who have low back or buttock pain that travels down one or both legs past the knee (sciatica) and has lasted for at least 3 months
• People whose pain has been rated more than 3 out of 10 in the past 24 hours (where 0 means no pain and 10 means the worst pain imaginable)
• People who are willing to be randomly assigned to a treatment group
• Women who could become pregnant must agree to use an effective form of contraception for the duration of the study

Who may not be able to join:

• People with a known or suspected serious spine condition, such as cauda equina syndrome or a spinal fracture
• People who are scheduled for, or being considered for, spine surgery or a medical procedure for their sciatica during the study period
• People who have nerve-related weakness or other progressive or disabling neurological symptoms in a specific area
• People who have low back pain but without sciatica (leg pain past the knee)
• People with an unstable digestive or gastrointestinal condition
• People with a history of a long-term or body-wide autoimmune disease that affects the digestive system
• People who developed diarrhea or blood in their stools within the month before the study begins
• People who took antibiotics within the month before the study starts
• Women who are pregnant or breastfeeding
• Women who could become pregnant will need a urine pregnancy test before the first scan and before receiving any study treatment — a positive result would mean the person could not continue in the study
• People with cognitive impairment, or a history of psychiatric conditions suggesting mental health instability
• People who are likely to move away during the trial, have no reliable transport, or would not be available at required sample collection times
• People who have a condition that affects their blood's ability to clot normally
• People currently taking blood-thinning medications such as Heparin or Warfarin
• People currently taking two antiplatelet medications together, such as aspirin combined with Plavix (clopidogrel)
• People with significantly abnormal liver or kidney function results on blood tests, as defined by specific laboratory thresholds (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.