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NCT Number: NCT06252948

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-interventional study (observational)

Other

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Other names: GMB

Primary outcomes

  1. Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders

    Time frame: Baseline

    Stool samples will be collected by the patient using a stool self- collection kit provided to the participant by the study staff. Samples will be evaluated for characteristics of gut microbiome (α-diversity and β-diversity).

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Hawkins

CONTACT

[email protected]

507-538-1308

Sarah Aug

CONTACT

[email protected]

507538-1301

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: Microbiome

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Feb 12, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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