Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia
Enrolling by invitationPhase 2NCT06424041
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia: A Prospective Randomized, Controlled Double-Blind Study
- Conditions
- Interventions
- Other: Fecal Microbiome Transplantation
- Other: Sham Fecal Microbiome Transplantation
- Sponsor
- Rambam Health Care Campus
- Start date
- 2024-03-11
- Primary completion
- 2026-03
- Sex
- Female
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Israel
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06424041