Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT06817018
Eligibility Criteria:
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 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:
* unstable GI disorder
* 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 start
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. The clinical research coordinator will run the pregnancy test and inform the patient of the results. If the test is positive, they will be withdrawn from study participation.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 anticoagulant medications (e.g Heparin, Warfarin)
* taking dual antiplatelet medications (e.g. aspirin + Plavix)
* participants with clinically significant laboratory abnormalities of liver function (AST and ALT) and kidney function (BUN and serum creatinine) abnormalities. Definition of clinically significant for liver function is AST/ALT ≥ 3.0x ULN and for kidney function is serum creatinine \> 2.0 mg/dl and BUN \> 1.5x ULN.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06817018
Study Brief:
Protocol Section:
NCT06817018