Probiotics for Modic Changes in Low Back Pain Patients

Summary

Probiotics for spinal inflammatory end-plate changes, so-called Modic changes, a randomised controlled study

Modic changes are inflammatory end-plate changes primarily affecting the lower lumbar levels. They are associated with disc degeneration, disc herniation and age, and are only seen on magnetic resonance imaging of the lumbar spine, not on X-ray. Three different types of Modic changes have been described, type 1, 2 and 3, the latter being rare \[5\]. It has been shown that type 1, but not type 2, is associated with more intense low back pain (LBP) and worse LBP outcome including a lower rate of return to work \[7\]. In addition, more inflammatory cells have been identified in this type of structural abnormality \[25\]. Modic changes may affect up to 20% of the general population and more than the double proportion in clinical populations, type 1 and 2 being about equally represented \[6\]. The investigators have estimated that at least 5,000 of the patients, who are referred to secondary health care in Denmark for LBP per year, will suffer from type 1 Modic changes.

Based on a hypothesis of infection as the cause of Modic changes, a randomised clinical trial with one year follow-up has been performed \[16\]. This trial documented significant effect of long-term (100 days) broad-spectrum antibiotic treatment (amoxicillin/ clavulanic acid) in patients with type 1 Modic changes. However, infection in Modic changes has not been documented convincingly in this or in other studies, and almost all of the treatment effect occurred after the antibiotic treatment was stopped. As yet, the study has not been replicated. The investigators hypothesize that the treatment effect may have been caused by an effect on the gut microbiom possibly explaining the delay of the effect.

Probiotics have been shown to influence interleukins in patients with inflammatory conditions and in healthy volunteers \[32, 36, 37\].

The investigators are therefore performing a randomised trial to study the clinical effect of probiotics on type 1 Modic changes as well as the effect on interleukin levels. The trial is designed as a randomised, clinical, double blind, placebo-controlled trial taking place at the Spine Center, Silkeborg Regional Hospital. Power calculation was based on a smaller treatment effect than the effect found in the study above and resulted in the requirement of including 94 patients. One-year follow-up is planned.

The investigators use lactobacillus rhamnosus GG (Dicoflor®) for the trial, as this strain has been used in several clinical studies. The dietary supplement has been shown to influence relevant interleukins significantly, and it has been proven to be stable in action and safe, also in pregnancy.

A positive result of such a trial may have significant consequences. The perspective of using probiotics instead of antibiotics in this common disorder is very attractive. At the time being, many type 1 Modic patients in Denmark and other western countries are treated with antibiotics. This is of great concern because of side effects and possible drug resistance development of bacteria.

The Technology Transfer Office of Aarhus University is involved.

Conditions

• Low Back Pain

Interventions

DIETARY_SUPPLEMENT

Probiotic

Lactobacillus rhamonosus GG

OTHER

Inactive capsules

Placebo

Sponsors & Collaborators

• The Danish Rheumatism Association

  collaborator OTHER

• Ole Kudsk Jensen

  lead OTHER

Principal Investigators

• Ole Kudsk Jensen, MD · Hospitalsenhed Midt, Region Midtjylland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-14

Primary Completion

2018-04-07

Completion

2018-04-07

Countries

• Denmark

Study Locations