FibromyalgiaPhase 2FM-FMT-RCTNCT06424041
Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia
A Phase 2 study testing Fecal Microbiome Transplantation in people with Fibromyalgia, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Fecal Microbiome Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Mar 2024to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia: A Prospective Randomized, Controlled Double-Blind Study
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.
Read the detailed description
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 microbiome composition correlated with clinical indices of the syndrome. Building upon this knowledge, the study seeks to explore the therapeutic potential of FMT, a well-established treatment increasingly investigated across various medical conditions. Preclinical investigations in mice have shown that FMT from fibromyalgia patients induces symptoms of the syndrome, while FMT from healthy controls reverses them. Encouragingly, preliminary results from an open-label pilot clinical trial involving fibromyalgia patients receiving encapsulated oral FMT from healthy donors demonstrated significant improvements in pain intensity, symptomatic burden, and quality of life measures, with favorable safety profiles. Based on these promising findings, a prospective randomized, controlled double-blind study is proposed to further evaluate the efficacy and safety of encapsulated oral FMT from healthy individuals in fibromyalgia patients. Clinical outcomes, as well as stool and serum samples, will be extensively characterized to elucidate the mechanisms underlying the effects of FMT, including its modulation of gut microbiome composition and function. The hypotheses involve expecting clinically significant improvements in pain and other symptoms of fibromyalgia following FMT, alongside corresponding alterations in gut microbiome composition and metabolomics profiles. This study aims to contribute valuable insights into the potential role of FMT as a novel therapeutic approach for fibromyalgia, addressing an unmet need in the management of this challenging condition.
- Conditions
- Fibromyalgia
- Being tested
- Fecal Microbiome Transplantation, Sham Fecal Microbiome Transplantation
- Keywords
- Fibromyalgia, Fecal Microbiome Transplantation (FMT), Microbiome, Chronic Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiome TransplantationOther
Healthy donor fecal microbiome transplantation, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing
Sham Fecal Microbiome TransplantationOther
Capsules containing preservative solution only, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Fecal Microbiome Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week five post transplantation induction
Secondary outcomes (4)
overall symptomatic burden
As measured using the Fibromyalgia Impact Questionnaire (range 0-100, higher scores indicate worse symptoms)
Measured: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Anxiety and depression
As assessed by the Hospital Anxiety and Depression Scale questionnaire (range 0-21 for each of the domains, higher scores indicate worse symptoms)
Measured: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Sleep quality
As assessed by the Pittsburgh Sleep Quality Inventory (range 0-21, higher scores indicate worse sleep quality).
Measured: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Quantitative Sensory Testing
Pressure, heat and cold pain thresholds (Kg/cm^2, degrees C respectively, lower thresholds indicate increased pain sensitivity)
Measured: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start11 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double-Blinded, Randomized Placebo-Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Minerbi MD, Rambam Health Care Campus
- Investigators
- Amir Minerbi, MD-PhD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424041
- Sponsor's protocol ID
- 0521-23
- Other IDs
- Weston Family Foundation, Israel Science Foundation
- Acronym
- FM-FMT-RCT
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia: A Prospective Randomized, Controlled Double-Blind Study
- ClinicalTrials.gov ID
- NCT06424041
- Acronym / sponsor ID
- FM-FMT-RCT / 0521-23
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Fecal Microbiome Transplantation (FMT), Microbiome, Chronic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 microbiome composition correlated with clinical indices of the syndrome. Building upon this knowledge, the study seeks to explore the therapeutic potential of FMT, a well-established treatment increasingly investigated across various medical conditions. Preclinical investigations in mice have shown that FMT from fibromyalgia patients induces symptoms of the syndrome, while FMT from healthy controls reverses them. Encouragingly, preliminary results from an open-label pilot clinical trial involving fibromyalgia patients receiving encapsulated oral FMT from healthy donors demonstrated significant improvements in pain intensity, symptomatic burden, and quality of life measures, with favorable safety profiles. Based on these promising findings, a prospective randomized, controlled double-blind study is proposed to further evaluate the efficacy and safety of encapsulated oral FMT from healthy individuals in fibromyalgia patients. Clinical outcomes, as well as stool and serum samples, will be extensively characterized to elucidate the mechanisms underlying the effects of FMT, including its modulation of gut microbiome composition and function. The hypotheses involve expecting clinically significant improvements in pain and other symptoms of fibromyalgia following FMT, alongside corresponding alterations in gut microbiome composition and metabolomics profiles. This study aims to contribute valuable insights into the potential role of FMT as a novel therapeutic approach for fibromyalgia, addressing an unmet need in the management of this challenging condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-Blinded, Randomized Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Active Treatment - FMT | Active comparator | Other: Fecal Microbiome TransplantationParticipants 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. |
| Sham Treatment - FMT | Sham comparator | Other: Sham Fecal Microbiome TransplantationParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiome TransplantationHealthy donor fecal microbiome transplantation, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing | Other | Active Treatment - FMT |
| Sham Fecal Microbiome TransplantationCapsules containing preservative solution only, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing | Other | Sham Treatment - FMT |
Primary outcome
Pain intensity at week five post-transplantation
Time frame: 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.
4 secondary outcomes
overall symptomatic burden
Time frame: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Anxiety and depression
Time frame: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Sleep quality
Time frame: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Quantitative Sensory Testing
Time frame: Week five post transplantation induction and then on months 1, 3, 6 after last FMT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Minerbi, MD-PhD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiome Transplantation in people with Fibromyalgia, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at week five post-transplantation (time frame: Week five post transplantation induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.