Who is sponsoring FM-FMT-RCT?

FM-FMT-RCT is sponsored by Rambam Health Care Campus.

What condition does FM-FMT-RCT study?

FM-FMT-RCT studies Fibromyalgia.

What drugs are being tested in FM-FMT-RCT?

Interventions: Fecal Microbiome Transplantation, Sham Fecal Microbiome Transplantation.

What is the status of FM-FMT-RCT?

FM-FMT-RCT is currently ENROLLING_BY_INVITATION.

Last reviewed 2024-05-16 · How we verify

Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia: A Prospective Randomized, Controlled Double-Blind Study (FM-FMT-RCT)

NCT06424041 Phase 2 ENROLLING_BY_INVITATION

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.

Details

Lead sponsor	Rambam Health Care Campus
Phase	Phase 2
Status	ENROLLING_BY_INVITATION
Enrolment	100
Start date	2024-03-11
Completion	2027-03

Conditions

Fibromyalgia

Interventions

Fecal Microbiome Transplantation
Sham Fecal Microbiome Transplantation

Primary outcomes

Pain intensity at week five post-transplantation — Week five post transplantation induction
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.

Countries

Israel