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:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT06771492
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-65 years.
* Chronic low back pain (i.e. duration \>6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.
* At least 2 of the following questions should be answered with "Yes":
* Does training and/or exercise increase your pain?
* Is your sleep during the night disturbed due to your back pain?
* Is it painful to turn over in bed at night?
* Do you suffer from morning pain?
* The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.
* Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.
Exclusion Criteria:
* Received antibiotic treatment in the past month.
* Current pregnancy, lactation or pregnancy-wish.
* Severe physical or psychiatric co-morbidities.
* LBP resulting from a specific cause such as a tumor or fracture.
* Surgery or epidural injection in the past 6 months.
* Previous antibiotic course of 100 days.
* Contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU)
* Contra-indication for MRI.
* Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid.
* Hepatic or renal (eGFR≤30) impairment.
* Inability to swallow capsules.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06771492
Study Brief:
Protocol Section:
NCT06771492