Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia

NCT06424041 | Enrolling By Invitation Phase 2

• 3 other identifiers: 0521-23Weston Family FoundationIsrael Science Foundation
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Fecal Microbiome Transplantation (FMT); Microbiome; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity at week five post-transplantation

  Pain intensity will be assessed using the Visual Analogue Scale (VAS), with a score of zero indicating no pain and a score of 10 representing the worst possible pain.

  Week five post transplantation induction

Secondary Outcomes (4)

• overall symptomatic burden

  Week five post transplantation induction and then on months 1, 3, 6 after last FMT

• Anxiety and depression

  Week five post transplantation induction and then on months 1, 3, 6 after last FMT

• Sleep quality

  Week five post transplantation induction and then on months 1, 3, 6 after last FMT

• Quantitative Sensory Testing

  Week five post transplantation induction and then on months 1, 3, 6 after last FMT

Study Arms (2)

Active Treatment - FMT

ACTIVE COMPARATOR

Participants in this arm will receive a total of 5 real FMT treatments administered weekly, followed by an additional 5 maintenance FMT treatments on a monthly basis. The first induction treatment will consist of 30 grams, with subsequent treatments comprising 15 grams each.

Other: Fecal Microbiome Transplantation

Sham Treatment - FMT

SHAM COMPARATOR

Participants in this arm will receive a total of 5 sham FMT treatments administered weekly, followed by an additional 5 maintenance sham FMT treatments on a monthly basis. The first induction treatment will consist of 30 grams, with subsequent treatments comprising 15 grams each.

Other: Sham Fecal Microbiome Transplantation

Interventions

Fecal Microbiome Transplantation OTHER

Healthy donor fecal microbiome transplantation, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing

Active Treatment - FMT

Sham Fecal Microbiome Transplantation OTHER

Capsules containing preservative solution only, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing

Sham Treatment - FMT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women aged 18-75 years.
• Diagnosis of fibromyalgia confirmed according to the 2016 diagnostic criteria by a pain physician who is a part of the study team.
• An average reported pain of 6 or above during the preceding week.
• Has remained symptomatic despite receiving standard care for fibromyalgia.

You may not qualify if:

• Any active inflammatory condition (rheumatic, gastrointestinal or other).
• Malignant neoplasm in the preceding 5 years.
• Immunosuppression due to medical condition or treatment.
• Uncontrolled psychiatric pathology.
• Any other clinically important condition at the discretion of the investigator.
• Known allergy to the antibiotics or laxatives used in the preparation protocol, or severe food allergy.
• Pregnancy or intention to conceive.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, North, 3109601, Israel

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Amir Minerbi, MD-PhD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Model Details: A Double-Blinded, Randomized Placebo-Controlled Trial

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 21, 2024
• Study Start: March 11, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)