Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia

A double-blind, randomized placebo-controlled study to test the therapeutic potential of encapsulated oral fecal microbiota transplantation (FMT) from healthy donors to humans with fibromyalgia.

Fibromyalgia, a chronic and debilitating syndrome characterized by widespread pain, fatigue, sleep disturbances, and cognitive dysfunction poses a significant clinical, social, and economic burden globally, with limited targeted treatment options available. Recent studies have shed light on the potential role of the gut microbiome in fibromyalgia pathogenesis, highlighting alterations in gut microbiome composition correlated with clinical indices of the syndrome. Building upon this knowledge, the study seeks to explore the therapeutic potential of FMT, a well-established treatment increasingly investigated across various medical conditions. Preclinical investigations in mice have shown that FMT from fibromyalgia patients induces symptoms of the syndrome, while FMT from healthy controls reverses them. Encouragingly, preliminary results from an open-label pilot clinical trial involving fibromyalgia patients receiving encapsulated oral FMT from healthy donors demonstrated significant improvements in pain intensity, symptomatic burden, and quality of life measures, with favorable safety profiles. Based on these promising findings, a prospective randomized, controlled double-blind study is proposed to further evaluate the efficacy and safety of encapsulated oral FMT from healthy individuals in fibromyalgia patients. Clinical outcomes, as well as stool and serum samples, will be extensively characterized to elucidate the mechanisms underlying the effects of FMT, including its modulation of gut microbiome composition and function. The hypotheses involve expecting clinically significant improvements in pain and other symptoms of fibromyalgia following FMT, alongside corresponding alterations in gut microbiome composition and metabolomics profiles. This study aims to contribute valuable insights into the potential role of FMT as a novel therapeutic approach for fibromyalgia, addressing an unmet need in the management of this challenging condition.

Inclusion criteria

• Adult women aged 18-75 years.
• Diagnosis of fibromyalgia confirmed according to the 2016 diagnostic criteria by a pain physician who is a part of the study team.
• An average reported pain of 6 or above during the preceding week.
• Has remained symptomatic despite receiving standard care for fibromyalgia.

Exclusion criteria

• Any active inflammatory condition (rheumatic, gastrointestinal or other).
• Malignant neoplasm in the preceding 5 years.
• Immunosuppression due to medical condition or treatment.
• Uncontrolled psychiatric pathology.
• Any other clinically important condition at the discretion of the investigator.
• Known allergy to the antibiotics or laxatives used in the preparation protocol, or severe food allergy.
• Active infection or expected antibiotic treatment in the upcoming 3 months after inclusion.
• Pregnancy or intention to conceive.