Enrolling by invitationPhase 2

Gut bacteria transplants from healthy donors for women with fibromyalgia

Tests fecal microbiome transplantation against a sham treatment in women with severe fibromyalgia.

Key facts

Who runs it: Rambam Health Care Campus
Where: Israel1 site in 1 countryChoose a country to see its sites
Trial code: NCT06424041
Registry title: Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia
Status: Enrolling by invitation
Phase: Phase 2
People taking part: 100 people, planned
Started: 11 Mar 2024
Expected to end: Mar 2027
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Fecal Microbiome Transplantation
Sham Fecal Microbiome Transplantation
Record updated: 21 May 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women with severe fibromyalgia, a long-lasting pain condition. They will get stool bacteria from healthy donors (fecal microbiome transplantation) or a sham treatment.

Age: 18 to 75 years
Sex: Women only
Disease stage: Fibromyalgia confirmed by a pain doctor on the study team, using the 2016 diagnostic criteria. Average pain of 6 or above during the past week.
Earlier treatment: Symptoms must still be present despite standard care for fibromyalgia.

Main reasons for not taking part

Any active inflammatory condition, such as rheumatic or gut disease
Cancer in the past 5 years
A weak immune system due to illness or treatment
Psychiatric illness that is not under control
Active infection or expected antibiotic treatment in the 3 months after joining, or allergy to the antibiotics or laxatives used, or severe food allergy, or pregnancy or plans to become pregnant

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

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

Who cannot take part

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
Active infection or expected antibiotic treatment in the upcoming 3 months after inclusion
Pregnancy or intention to conceive

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

Active Treatment - FMTExisting treatment, for comparison
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.
Treatment: Fecal Microbiome Transplantation
Sham Treatment - FMTSham treatment, for comparison
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.
Treatment: Sham Fecal Microbiome Transplantation