Bifidobacterium treatment for chronic low back pain in patients with Modic changes: study protocol for a multicenter, randomized, placebo-controlled trial.

Sunqi Nian, Chengjin Li, Na Li, Fei Chen, Caiwang Zhao, Guangyao Zhang, Sheng Lu, Jiayu Chen

Journal: Trials 2025;26(1):347

PMID: 40993700

Abstract

BACKGROUND

Low back pain (LBP) is a major global health issue, affecting approximately two-thirds of the population at some point in their lives. Modic changes (MCs) in the vertebral endplates, as observed on MRI, are recognized contributors to LBP and may be linked to advanced stages of intervertebral disc degeneration (IDD). Prior research has shown a decrease in the genus Bifidobacterium in the endplate cartilage of patients with IDD and concurrent MCs. The potential link between reduced Bifidobacterium levels and MC-related LBP remains unclear.

METHODS

This multicenter, double-blinded, randomized, placebo-controlled trial will be conducted at four hospitals in China, comparing the efficacy of orally administered Bifidobacterium adolescentis (BA) with that of a placebo. Participants will receive the treatment twice daily for a duration of three months. The study targets patients with chronic low back pain (LBP) and Modic type I or II. Eligible patients will be randomly assigned to receive either Bifidobacterium adolescentis or a placebo for three months. The primary outcome will be the change in the Simplified Chinese Roland-Morris Disability Questionnaire (SCRMDQ) score at 3, 6, and 12 months post-treatment. Secondary outcomes include changes in DASS-21 scores, MRI imaging, bone density measurements, and serum biomarker analysis.

DISCUSSION

This study will provide valuable insights into the therapeutic potential of Bifidobacterium adolescentis in managing chronic LBP associated with Modic changes, potentially offering a novel approach to treating this common and debilitating condition.

TRIAL REGISTRATION

The trial has been registered with China Clinical Trial Registry, under the registration number ChiCTR2400088577. Registered on 21 August. The study was prospectively registered.

Address: The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China.; Department of Orthopedics, The First People's Hospital of Yunnan Province, Yunnan, China.; The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China.; Department of Anesthesiology, 920, Hospital of the Joint Logistics Support Force, Kunming, Yunnan, China.; The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China. [email protected].; Department of Orthopedics, The First People's Hospital of Yunnan Province, Yunnan, China. [email protected].; The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China. [email protected].; Department of Orthopedics, The First People's Hospital of Yunnan Province, Yunnan, China. [email protected].

DOI: 10.1186/s13063-025-09084-2

MeSH Terms: Humans, Low Back Pain, Double-Blind Method, Probiotics, Treatment Outcome, Multicenter Studies as Topic, China, Randomized Controlled Trials as Topic, Chronic Pain, Magnetic Resonance Imaging, Adult, Bifidobacterium adolescentis, Male, Female, Middle Aged, Time Factors, Pain Measurement, Disability Evaluation, Intervertebral Disc Degeneration, Administration, Oral, Lumbar Vertebrae