Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia
Run by Rambam Health Care Campus · NCT06424041 · Data updated 2026-11-12
Enrolling by invitation only. This study is not taking new participants. Its registered completion date is 2026-03.
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, improve…
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Rambam Health Care Campus Academic / other |
| Drugs / interventions | Fecal Microbiome Transplantation, Sham Fecal Microbiome Transplantation |
| Locations | 1 site (Israel) |
| Trial ID | NCT06424041 on ClinicalTrials.gov |
What this trial studies
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 individua…
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult women aged 18-75 years. 2. Diagnosis of fibromyalgia confirmed according to the 2016 diagnostic criteria by a pain physician who is a part of the study team. 3. An average reported pain of 6 or above during the preceding week. 4. Has remained symptomatic despite receiving standard care for fibromyalgia. Exclusion Criteria: 1. Any active inflammatory condition (rheumatic, gastrointestinal or other). 2. Malignant neoplasm in the preceding 5 years. 3. Immunosuppression due to medical condition or treatment. 4. Uncontrolled psychiatric pathology. 5. Any other clinically important condition at the discretion of the investigator. 6. Known allergy to the antibiotics or laxatives used in the preparation protocol, or severe food allergy. 7. Active infection or expected antibiotic treatment in the upcoming 3 months after inclusion. 8. Pregnancy or intention to conceive.
Where it's running
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Rambam Health Care Campus
Haifa, North, Israel
Study contacts
- Principal investigator: Amir Minerbi, MD-PhD — Rambam Health Care Campus
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.