Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia

Launched by RAMBAM HEALTH CARE CAMPUS · May 16, 2024

Keywords

ClinConnect Summary

This is a phase 2, double‑blind study asking whether capsules containing healthy donor gut bacteria (fecal microbiome transplantation, or FMT) can reduce fibromyalgia symptoms. After an antibiotic and bowel-cleansing prep, participants take a total of 10 FMT sessions: 5 weekly doses to start, then 5 maintenance doses monthly. The main goal is to see if pain levels improve by about 5 weeks after starting treatment (measured on a 0–10 scale). Researchers will also look at overall symptoms, anxiety and mood, sleep quality, and pain sensitivity at several follow‑ups over the next 6 months.

Who can join? Adult women aged 18–75 with fibromyalgia diagnosed by a study doctor and who have average pain of 6/10 or higher in the past week, despite standard care. Exclusions include active inflammatory diseases, recent cancer, pregnancy, immune problems, or certain other health conditions. The study is at Rambam Health Care Campus in Haifa, Israel, and is enrolling by invitation with about 80 women planned. If you participate, you’ll be randomly assigned to real FMT or a sham (placebo) treatment, and neither you nor the staff will know who’s in which group during the study. Blood and stool tests will be done to study changes in gut bacteria and related work. Results are not yet known.

Gender

FEMALE

Eligibility 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.