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

Overseen By Eugene Yen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eugene F Yen, MD

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the antibiotic rifaximin for treating microscopic colitis, a condition causing frequent and watery stools. The study involves patients taking the medication regularly over a period of weeks. The goal is to see if it reduces inflammation and improves symptoms by lowering gut bacteria levels. Rifaximin is a non-absorbable antibiotic derived from rifamycin, used to treat various intestinal bacterial infections and inflammatory bowel diseases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Rifaximin generally safe for human use?

Rifaximin is considered safe for human use, as it is poorly absorbed in the gut, minimizing systemic side effects. It has been used effectively for various gastrointestinal conditions with minimal adverse reactions reported. ^{1 2 3 4 5}

Research Team

Eugene Yen, MD

Principal Investigator

Endeavor Health

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label rifaximin 550mg three times per day for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Rifaximin

Participant Groups

Group I: Drug Experimental Treatment 1 Intervention

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

Rifaximin is already approved in United States, Canada, European Union, India for the following indications:

Approved in United States as Xifaxan for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Approved in Canada as Zaxine for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Approved in European Union as Xifaxan for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Approved in India as Ciboz and Xifapill for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Who Is Running the Clinical Trial?

Eugene F Yen, MD

Lead Sponsor

Trials

1

Recruited

10+

Findings from Research

Rifaximin is effective in treating travelers' diarrhea caused by Escherichia coli, showing similar efficacy to ciprofloxacin, but it does not work against Campylobacter jejuni infections.

Beyond travelers' diarrhea, rifaximin has potential uses in treating various gastrointestinal disorders, including hepatic encephalopathy and Crohn's disease, due to its broad spectrum of activity and poor absorption in the gastrointestinal tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rifaximin: a nonabsorbed oral antibiotic. Baker, DE.[2018]

In a study involving 43 patients with liver cirrhosis, both low-dose (800 mg/day) and high-dose (1200 mg/day) rifaximin significantly reduced serum endotoxin levels after 2 weeks, indicating effective management of endotoxemia.

The effects of high-dose rifaximin persisted for at least 4 weeks after treatment cessation, and the safety profile was similar across all groups, suggesting that lower doses may be just as effective without increasing risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does low-dose rifaximin ameliorate endotoxemia in patients with liver cirrhosis: a prospective study. Zeng, X., Tang, XJ., Sheng, X., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rifaximin: a nonabsorbed oral antibiotic. [2018]

2. Egypt pubmed.ncbi.nlm.nih.gov

Synergic Interaction of Rifaximin and Mutaflor (Escherichia coli Nissle 1917) in the Treatment of Acetic Acid-Induced Colitis in Rats. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Chronic Rifaximin Use in Cirrhotic Patients Is Associated with Decreased Rate of C. difficile Infection. [2020]

4. Australia pubmed.ncbi.nlm.nih.gov

Does low-dose rifaximin ameliorate endotoxemia in patients with liver cirrhosis: a prospective study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Rifaximin: beyond the traditional antibiotic activity. [2018]