Evaluating gut microbiome in patients with POEMS syndrome and other plasma cell disorders
Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
This study looks at the gut bacteria in people with POEMS syndrome and other plasma cell disorders to see how it differs from healthy individuals and how it might change between active disease and remission.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06252948 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the characteristics and role of the gut microbiome in patients with POEMS syndrome and other plasma cell disorders, such as AL amyloidosis. Researchers will analyze stool samples from newly diagnosed POEMS patients and compare them with samples from patients with other plasma cell disorders and healthy controls. The study will also examine differences in gut microbiome signatures between active disease and remission in POEMS patients. The goal is to enhance understanding of the relationship between gut microbiome and these rare disorders.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with POEMS syndrome, AL amyloidosis, multiple myeloma, or monoclonal gammopathy of undetermined significance.
Not a fit: Patients under 18 years, pregnant individuals, or those with chronic gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the gut microbiome's role in plasma cell disorders, potentially leading to new therapeutic strategies.
How similar studies have performed: While the specific focus on gut microbiome in POEMS syndrome is novel, similar studies in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with POEMS syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (MM), monoclonal gammopathy of undetermined significance (MGUS), amyloid light chain (AL) amyloidosis or healthy controls from their households Exclusion Criteria: * Age under 18 years * Pregnancy * Substance abuse * Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation * Chronic gastrointestinal disorder * Gastrointestinal surgeries in the past 2 years * Chemotherapy (including anti-plasma cell treatment and steroids) or radiation treatment for cancer within the last 2 years or active cancer (other than plasma cell disorder)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Angela Dispenzieri, M.D. — Mayo Clinic in Rochester
- Study coordinator: Laura Hawkins
- Email: hawkins.laura@mayo.edu
- Phone: 507-538-1308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.