MSK ConditionsPhase 3ABBANCT06771492

Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

A Phase 3 study testing Amoxicillin in people with MSK Conditions and Chronic Low Back Pain (CLBP), run by Bart Koes at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "Modic type I change." The main questions the trial aims to answer are: What is… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: MSK Conditions, Chronic Low Back Pain (CLBP), Modic Changes
What is being tested?: Amoxicillin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 1 siteNetherlands
Study dates: 2 Apr 2025to Aug 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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?

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Erasmus Medical Center
Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

The main questions the trial aims to answer are:

What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?
What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes?

Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain.

Participants in the trial will:

Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study.
Take either amoxicillin or a placebo daily for 100 days.
Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics.
Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests.
Complete questionnaires at baseline, 3 months, 6 months, and 12 months.

Conditions: MSK Conditions, Chronic Low Back Pain (CLBP), Modic Changes
Being tested: Amoxicillin, Placebo
Keywords: Antibiotics, Amoxicillin, Low back pain (LBP), Modic changes, Randomized controlled trial
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AmoxicillinDrug
Antibiotic treatment (amoxicillin) with a dosage of 1000 mg (3 times a day) for a period of 100 days
PlaceboOther
Placebo with a dose of 1000 mg (3 times a day) for a period of 100 days

Study groups in NCT06771492
Study group	Role	What they receive
Antibiotic treatment (amoxicillin)	Experimental	A dose of 1000 mg (3 times a day) for a period of 100 days Receives: Drug: Amoxicillin
Placebo	Placebo comparator	A dose of 1000 mg (3 times a day) for a period of 100 days Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Roland Morris Disability Questionnaire (RMDQ)
The primary outcome is pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ). The scale ranges from 0-24 in which a higher score indicates higher disability. The RMDQ was also the primary outcome in the previous trials, and it is a recommended core outcome measure for trials in LBP.
Measured: The measurements are scheduled at baseline and at 3, 6 and 12 months follow-up.

Secondary outcomes (16)

LBP-intensity (0-10 NRS-scale)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Leg pain intensity (0-10 NRS-scale)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Health-related quality of life (PROMIS-GH-10)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Health-related quality of life (EQ-5D-5L)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Self-reported number of days with sick leave
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Co-interventions (pharmacological and non-pharmacological)
In the form of a questionnaire
Measured: Measured at baseline, 3 months and 12 months
Global perceived effect (7-point Likert scale)
In the form of a questionnaire
Measured: Measured at 3 months, 6 months and 12 months
Patients' satisfaction with treatment (7-point Likert scale)
In the form of a questionnaire
Measured: Measured at baseline, 3 months and 12 months
Success of blinding
In the form of a questionnaire
Measured: Measured at 3 months and 12 months
Compliance
A pill count will be conducted
Measured: Measured at 3 months
Pain self-efficacy (Pain Self-Efficacy Questionnaire)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Sleep questionnaire (Pittsburgh Sleep Quality Index)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Neuropathic pain (PainDETECT)
In the form of a questionnaire
Measured: Measured at baseline, 3 months, 6 months and 12 months
Cost questionnaires (Medical Consumption Questionnaire)
In the form of a questionnaire
Measured: Measured at 3 months, 6 months and 12 months
Cost questionnaires (Productivity Cost Questionnaire)
In the form of a questionnaire
Measured: Measured at 3 months, 6 months and 12 months
Gut microbiome composition
The possible collateral impact of antibiotics on the microbiome would be investigated by comparing the abundance and diversity of microbial and resistome composition between patients in amoxicillin and placebo groups. They would be characterized using whole shotgun and functional metagenomic sequencing data (Dhariwal et al. Gut Microbes, 2023).
In short, stools of the patients will be collected at baseline, 3 months, and 12 months. From these samples, the microbial DNA will be extracted using a commercial kit. Libraries for shotgun metagenomic sequencing would be prepared using Ilumina sequencing platform. Low quality and adapter sequences from paired-end reads will be filtered, and human DNA contaminant sequences will be discarded. The high-quality reads will be subjected to taxonomic classification. CARD antimicrobial resistance database will be used to annotate metagenomic reads.
Measured: Measured at baseline, 3 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 2025Aug 2027

First posted13 Jan 2025
Study start2 Apr 2025
Primary completionAug 2027 (estimated)
Study completionAug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for MSK ConditionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 144 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06771492
Sponsor's protocol ID: 2024-515824-35
Other IDs: 2024-515824-35-01
Acronym: ABBA
Status last verified: Sep 2026
First submitted: 21 Nov 2024
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104
Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
PubMed 35507483
Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13.
PubMed 23404353
Braten LCH, Rolfsen MP, Espeland A, Wigemyr M, Assmus J, Froholdt A, Haugen AJ, Marchand GH, Kristoffersen PM, Lutro O, Randen S, Wilhelmsen M, Winsvold BS, Kadar TI, Holmgard TE, Vigeland MD, Vetti N, Nygaard OP, Lie BA, Hellum C, Anke A, Grotle M, Schistad EI, Skouen JS, Grovle L, Brox JI, Zwart JA, Storheim K; AIM study group. Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial. BMJ. 2019 Oct 16;367:l5654. doi: 10.1136/bmj.l5654.
PubMed 31619437
Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
PubMed 29971708
Agamennone V, Krul CAM, Rijkers G, Kort R. A practical guide for probiotics applied to the case of antibiotic-associated diarrhea in The Netherlands. BMC Gastroenterol. 2018 Aug 6;18(1):103. doi: 10.1186/s12876-018-0831-x.
PubMed 30078376
Jafarnejad S, Shab-Bidar S, Speakman JR, Parastui K, Daneshi-Maskooni M, Djafarian K. Probiotics Reduce the Risk of Antibiotic-Associated Diarrhea in Adults (18-64 Years) but Not the Elderly (>65 Years): A Meta-Analysis. Nutr Clin Pract. 2016 Aug;31(4):502-13. doi: 10.1177/0884533616639399. Epub 2016 Apr 29.
PubMed 27130655