Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia

Launched by RAMBAM HEALTH CARE CAMPUS · May 16, 2024

Keywords

ClinConnect Summary

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 microb...

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.

Trial Officials