
A collaborative project of investigators from McGill University, Rambam Health Campus and the Technion provides compelling evidence that gut microbiota may play a causal role in fibromyalgia (FM), a prevalent syndrome characterized by widespread pain in the absence of evident tissue injury or pathology. The study, which involved transplanting gut bacteria from FM patients into mice and a pilot clinical trial involving women with severe, refractory FM suggests that targeting the gut microbiome could offer a novel therapeutic approach for this debilitating disorder.
Fibromyalgia affects millions globally, predominantly women, for which effective treatments remain elusive. In this study led by Arkady Khoutorsky and Yoram Shir (from McGill University, both graduates of the Hebrew University of Jerusalem) and Amir Minerbi (Technion Faculty of Medicine, Director of the Institute of Pain Medicine of Rambam Health Campus) the investigators showed that transferring fecal microbiota from individuals with FM, but not from healthy individuals, into germ-free mice induced persistent pain hypersensitivity which mimicked key features of FM. Over time, the mice also exhibited depression-like behavior, a common comorbidity in FM patients. Furthermore the study showed that pain hypersensitivity in such mice could be reversed by subsequently transplanting microbiota from healthy individuals.
Building on these preclinical findings, the researchers conducted an open-label pilot study in 14 women with severe, refractory FM who received fecal microbiota transplantation from healthy female donors. The results showed clinically and statistically significant decreases in pain intensity and overall symptom burden, including improvements in fatigue, sleep quality, anxiety, and depression scores.
Building on these preclinical findings, the researchers conducted an open-label pilot study in 14 women with severe, refractory FM who received fecal microbiota transplantation from healthy female donors. The results showed clinically and statistically significant decreases in pain intensity and overall symptom burden, including improvements in fatigue, sleep quality, anxiety, and depression scores.
"Our findings in mice strongly suggest that the gut microbiota is not just altered in fibromyalgia, but may actively contribute to causing the widespread pain and other symptoms," said Dr. Minerbi. "The results from our pilot human study, while preliminary, are incredibly encouraging."
As the human pilot study was open-label and lacked a control group, larger, randomized controlled trials are already underway to confirm the efficacy and safety of this course of treatment. However, this research represents a crucial step forward in understanding the complex interplay between the gut microbiome and chronic pain conditions like fibromyalgia and underscores the growing importance of the gut-brain axis in understanding and treating chronic pain conditions.
The original article can be found here:
The gut microbiota promotes pain in fibromyalgia. doi: 10.1016/j.neuron.2025.03.032.
