NCT06252948

Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders

Detailed description

The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is the overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls.

Conditions

• Plasma Cell Disorders

Interventions

Type	Name	Description
OTHER	Non-interventional study (observational)	Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Timeline

• Start date: 2021-12-29
• Primary completion: 2028-12-01
• Completion: 2028-12-29
• First posted: 2024-02-12
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States