NCT04043897

Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Eugene F Yen, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.

Detailed description

This is an open-label single-arm trial to evaluate the efficacy of Rifaximin in patients with active microscopic colitis (MC). 10 subjects will be asked to take 500mg Rifaximin three times per day for 4 weeks. The primary endpoints will be histologic response and clinical remission (less than 3 stools per day and less than 1 watery stool per day within the prior 7 days. The secondary endpoint will be change of the MC Disease Activity Index (MCDAI).

Conditions

• Microscopic Colitis

Interventions

Type	Name	Description
DRUG	Rifaximin 550mg	Rifaximin 550mg

Timeline

• Start date: 2018-06-29
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-08-02
• Last updated: 2021-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study