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

NCT04043897 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EH17-360
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microscopic Colitis

Keywords

Microscopic Colitis

Outcome Measures

Primary Outcomes (2)

• Number of Subject Experiencing Remission of MC Symptoms

  Remission, which will be define as less than 3 stools per day and less than 1 watery stool per day within the prior 7 days as per Hjortswang criteria, which has been used as the standard definition of remission in most all randomized clinical trials evaluating budesonide and MC. Investigators will also look at number of bowel movements, abdominal pain, incontinence, and nocturnal bowel movements. Symptoms will be compared at Week 0 and Week 6.

  6 weeks

• Histologic Response for Indications of Disease Severity

  Our institution has identified histologic parameters associated with more severe disease activity. In collaboration with pathologists, investigators will compare histologic inflammation on patients before and after treatment. Histology will be assessed via standard H\&E staining, specifically looking at surface epithelial changes associated with disease severity.

  6 weeks

Secondary Outcomes (1)

• Change of the MC Disease Activity Index (MCDAI)

  6 weeks

Study Arms (1)

Drug

EXPERIMENTAL

Patients will receive open-label rifaximin 550mg tid x 4 weeks.

Drug: Rifaximin 550mg

Interventions

Rifaximin 550mg DRUG

Rifaximin 550mg

Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Collagenous colitis (CC) or lymphocytic colitis (LC) diagnosed on colon biopsies reviewed by 2 separate pathologists
• CC will be defined histologically to be the following: thickness of the collagenous subepithelial table \>10 micrometer using an ocular micrometer, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, lack of crypt architectural distortion, and regenerative-appearing changes in the surface and/or crypt epithelium
• LC will be defined histologically to be the following: intraepithelial lymphocytes \>20 per 100 epithelial cells in the subjective area of highest lymphocyte density, inflammation in the lamina propria consisting of mainly lymphocytes and plasma cells, and regenerative-appearing changes in the surface and/or crypt epithelium
• Subjects in active flare, defined as \>3 watery/loose stools per day on \>4 / 7 days over \>4 weeks in the past 3 months.

Sponsors & Collaborators

• Eugene F Yen, MD: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Microscopic

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Eugene Yen, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Amusin, BS

CONTACT

847-570-3558; damusin@northshore.org

Iris Chiou, BA

CONTACT

847-570-2138; ichiou@northshore.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor of Medicine

Model Details: Patients with a diagnosis of microscopic colitis will receive open-label rifaximin 550mg tid x 4 weeks.

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: August 2, 2019
• Study Start: June 29, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)