Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
ConditionPlasma Cell Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Age under 18 years
Pregnancy
Substance abuse
Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation
Trial population
POEMS Syndrome and Other Plasma Cell Disorders
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Non-interventional study (observational)
Other interventionParticipants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Treatment groups
240 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: MULTIPLE MYELOMA at diagnosis GROUP1 intervention
Group B: Amyloid at diagnosis GROUP1 intervention
Group C: Poems at diagnosis GROUP1 intervention
Group D: Poems in Remission GROUP1 intervention
Group E: MGUS GROUP1 intervention
Group F: Health controls in same household GROUP1 intervention
Trial outcomes
Primary outcomes
1
Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders
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).
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov