A Phase 2 interventional study of Rifaximin 550mg in Microscopic Colitis, sponsored by Eugene F Yen, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Eugene F Yen, MD · Phase 2, Interventional, and Treatment
This is an open label study looking at rifaximin therapy for the treatment of microscopic (collagenous or lymphocytic) colitis.
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).
23 studies on the registry are indexed under Colitis, Microscopic; 6 are open to participants now.
This study's planned enrollment of 10 is below the median of 47 across 14 interventional studies indexed under Colitis, Microscopic.
Browse Colitis, Microscopic studies →This is the only study on the registry with Eugene F Yen, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive open-label rifaximin 550mg tid x 4 weeks.
Drug: Rifaximin 550mg
Rifaximin 550mg
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.
Time frame: 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.
Time frame: 6 weeks
Change of the MC Disease Activity Index (MCDAI)
The MCDAI scale was developed to best predict a patient's quality of life as well as approximate a physician's global assessment. In multivariate analysis, the MCDAI demonstrated four independent clinical features associated with the physician global assessment including the number of unformed stools daily, number of nocturnal stools, abdominal pain, and number of episodes of fecal incontinence. These factors were used to develop estimated regression coefficients as weights produced the MCDAI formula: 1.1+0.31 (average number of unformed stools daily over the past week; continuous variable)+0.78 (nocturnal stools over past week, 0=absent, 1=present)+0.22 (maximum abdominal pain over past week, score 1-10)+0.11 (average weight loss per month (lbs))+0.93 (fecal urgency over past week, 0=absent, 1=present)+0.01 (number of episodes of fecal incontinence over past month; continuous variable). This will be assessed at Week 0 and at Week 6.
Time frame: 6 weeks
Plan to share: No
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Studies of the drug tested here: Rifaximin