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Can antibiotics cure a common form of back pain?

NCT ID NCT06771492

Disease control Sponsor: Bart Koes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether the antibiotic amoxicillin can reduce pain and disability in adults with chronic low back pain and a specific MRI finding called Modic type I change. Some scientists think bacteria in the spine may cause this type of pain. The trial compares 100 days of amoxicillin to a placebo in 144 adults aged 18 to 65 who have had low back pain for more than six months after a disc herniation. Participants also take probiotics to lessen antibiotic side effects and attend follow-up visits for a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amoxicillin, an antibiotic
What this could lead to
If it works, antibiotics could become a new way to treat a specific type of chronic low back pain tied to MRI changes, possibly reducing disability for people who do not respond to standard care.
What could go wrong
This is a Phase 3 trial, so the approach is still unproven. Antibiotics can cause side effects, and the pain may not improve if bacteria are not the cause. Long courses of antibiotics also raise concerns about resistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Low Back Pain musculoskeletal system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic low back pain (CLBP) Modic changes MSK conditions

Contacts and locations

Locations

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015 GD, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.