NCT06424041

Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia

Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia: A Prospective Randomized, Controlled Double-Blind Study

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate if a fecal microbiome transplantation (FMT) from healthy donors can reduce symptoms of fibromyalgia, a condition causing chronic pain that is difficult to treat and diagnose. Changes in the gut bacteria of women with fibromyalgia were previously reported, which might be linked to their symptoms. In mice studies, transferring gut bacteria from individuals with fibromyalgia was shown to increase sensitivity to pain, while treatment with antibiotics and transferring bacteria from healthy individuals reversed this effect. In a small open label trial in women, improvements in pain, fatigue, and sleep problems were observed after FMT. The investigators aim to perform a larger trial following a similar path. The study aims to conduct a double-blinded, randomized, placebo-controlled trial involving 80 women diagnosed with severe fibromyalgia. Half of the participants (40) will receive the active treatment, while the other half (40) will receive a sham treatment. The allocation to either group will be randomized. Throughout the study period, both the caregivers and the participants will remain unaware of their assigned groups until the study conclusion. Participants' symptoms will be documented and their blood and stool will be tested for changes in certain metabolites. If this treatment works, it could be a significant breakthrough in managing fibromyalgia and might provide new insights into its causes.

Detailed description

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
OTHER	Fecal Microbiome Transplantation	Healthy donor fecal microbiome transplantation, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing
OTHER	Sham Fecal Microbiome Transplantation	Capsules containing preservative solution only, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2024-05-21
• Last updated: 2024-05-21

Locations

1 site across 1 country: Israel