Schematic representation of the study design.
Credit: Neuron (2025). DOI: 10.1016/j.neuron.2025.03.032
McGill University-led research has discovered that transplanting gut microbiota from women with fibromyalgia into mice induces pain, immune activation, metabolomic changes, and reduced skin innervation.
The exact cause of fibromyalgia is unknown. Fibromyalgia affects 2% to 4% of the population, primarily women, and is characterized by chronic widespread pain, fatigue, sleep disruptions, and cognitive difficulties. Most patients suffer from significant symptoms that negatively impact quality of life.
Dysregulated activity of the central nervous system, altered neurotransmitters, neuroinflammation, and reduced intraepidermal nerve fiber density have been observed in fibromyalgia patients. Functional gastrointestinal disorders and depression are also common.
Previous studies have revealed that gut microbiota composition differs between women with fibromyalgia and healthy controls, yet the connection between this altered microbiota and any functional role it might play remains a mystery.
In the study, "The gut microbiota promotes pain in fibromyalgia," published in Neuron, researchers conducted a fecal microbiota transplantation study to determine whether altered gut microbiota from fibromyalgia patients could cause pain and related symptoms.
Researchers performed fecal microbiota transplantation (FMT) into germ-free female mice using samples collected from women with fibromyalgia and age-matched healthy controls. An open-label clinical trial enrolled 14 women with severe fibromyalgia who received five oral FMT doses from healthy female donors.
To assess pain and systemic changes in mice, the study employed behavioral assays, single-cell RNA sequencing, metabolomic profiling, dorsal root ganglia calcium imaging, and spinal microglia analysis. Clinical participants received oral FMT capsules biweekly for five doses following antibiotic and bowel cleansing preparation.
Mice that received microbiota from fibromyalgia patients developed mechanical, heat, and cold hypersensitivity, spontaneous pain, and muscle pain within four weeks. Persistent pain and depression-like behaviors were observed in mice four months post-transplantation.
Changes coincided with altered gut microbiota composition, immune activation marked by classical monocytes and spinal microglia, shifts in amino acid and bile acid metabolism, and reduced intraepidermal nerve fiber density. Replacing fibromyalgia-associated microbiota with that from healthy donors reversed pain hypersensitivity. Oral bile acid supplementation also reduced pain responses in mice.
In the human clinical study, 14 women with severe, treatment-resistant fibromyalgia received FMT from healthy donors. Post-treatment, 12 participants reported a clinically significant reduction in pain.
Improvements, while not complete reversals, were observed in overall symptom burden, sleep quality, anxiety, and depression scores. Quantitative sensory testing showed reductions in cold pain hypersensitivity. Stool analysis confirmed successful bacterial engraftment from healthy donors.
Based on the results, alterations in gut microbiota may play a causal role in the development of pain and other symptoms associated with fibromyalgia. Because the human trial was open-label, lacked a control arm, and enrolled only women, the findings are preliminary and need confirmation in randomized controlled trials.
Modulating the gut microbiota through fecal transplantation presents a potential therapeutic strategy for individuals suffering from this chronic pain syndrome. Establishing the functional significance of gut microbiota in fibromyalgia would open new opportunities for evaluating microbial-based interventions.
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