Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia

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

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

• Rambam Health Care Campus
  Haifa, North, Israel

Study contacts

• Principal investigator: Amir Minerbi, MD-PhD — Rambam Health Care Campus

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Calcium Gluconate After Birth to Reduce Blood Loss in Vaginal Delivery

  This study tests whether giving calcium gluconate right after the baby is born can help reduce blood loss for people having a vaginal delivery.

  Recruiting Rambam Health Care Campus · Haifa · NCT07714902

• Cervical ripening balloon left in place for 3 hours vs 12 hours during labor induction

  This study tests whether keeping the cervical ripening balloon in for 3 hours works as well as the standard 12 hours to shorten time to delivery in pregnant people induced for labor.

  Recruiting Rambam Health Care Campus · Haifa · NCT07689357

• Metamizole (Optalgin) impact on anti‑Xa levels in cancer patients on apixaban or rivaroxaban

  This study will test whether taking metamizole (Optalgin) changes anti‑Xa blood levels in adults with cancer who are taking apixaban or rivaroxaban.

  Recruiting Rambam Health Care Campus · Haifa · NCT07384013

• Y‑incision versus standard aortic root enlargement for people with a small aortic annulus

  This compares the Y‑incision versus standard surgical enlargement to see if surgeons can implant larger valves and reduce patient‑prosthesis mismatch in adults needing aortic valve replacement who have a small aortic annulus.

  Recruiting Rambam Health Care Campus · Haifa · NCT07368322

• Exploring how gut bacteria affect cannabis oil treatment in fibromyalgia patients

  This study is testing how gut bacteria might affect how well cannabis oil works for people with fibromyalgia.

  Recruiting Phase 2 Rambam Health Care Campus · Haifa · NCT06946940

• Changing high-flow nasal ventilation rate to see how CO2 levels respond in preterm infants

  This study will see if using a lower (2 LPM) versus higher (6 LPM) high-flow nasal ventilation rate changes carbon dioxide levels in preterm infants who need non-invasive breathing support.

  Recruiting Rambam Health Care Campus · Haifa · NCT06622902

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.