NCT03820817

Rifaximin in Patients With Monoclonal Gammopathy

Pilot Study of Oral Rifaximin in Patients With Monoclonal Gammopathy

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well rifaximin works in treating patients with monoclonal gammopathy. Antibiotics, such as rifaximin, may help to kill bacteria in the intestines and reduce the abnormal protein or cells in patients with monoclonal gammopathy.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the effect of a 2-week course of rifaximin on clonal immunoglobulin (Ig) in patients with monoclonal gammopathy. SECONDARY OBJECTIVES: I. To evaluate safety and tolerability of a 2-week course of rifaximin. II. To evaluate changes in stool microbiota by 16S ribosomal ribonucleic acid (rRNA) gene (16S) sequencing. III. To evaluate changes in gammopathy as assessed by changes in clonal Ig and/or plasma cells. OUTLINE: Patients receive rifaximin orally (PO) thrice daily (TID) on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 8 weeks.

Conditions

• IgA Monoclonal Gammopathy
• IgG Monoclonal Gammopathy
• IgM Monoclonal Gammopathy
• Light Chain Deposition Disease
• Monoclonal Gammopathy
• Smoldering Waldenstrom Macroglobulinemia
• Waldenstrom Macroglobulinemia
• Gammopathy, Monoclonal
• Gammopathy Igg

Interventions

Type	Name	Description
DRUG	Rifaximin	Given PO

Timeline

• Start date: 2019-05-15
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2019-01-29
• Last updated: 2025-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study