Rifaximin for Bloating in Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Baha Moshiree, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Wake Forest University Health Sciences

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing rifaximin, an antibiotic, to help people with cystic fibrosis who have gut symptoms like bloating. The antibiotic works by balancing gut bacteria to reduce discomfort. Rifaximin has been used to treat travelers' diarrhea and other conditions, and it has shown effectiveness in reducing symptoms of irritable bowel syndrome (IBS).

Research Team

Baha Moshiree, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for children and adults over 12 years old, weighing more than 30 kilograms, with confirmed cystic fibrosis experiencing bloating. Participants must not have severe lung impairment or recent antibiotic use and should be able to swallow pills whole. Pregnant women or those trying to conceive are excluded.

Inclusion Criteria

I am diagnosed with cystic fibrosis and registered with the CFF.

I am 12 years or older and weigh at least 66 pounds.

I experience moderate to severe abdominal swelling or bloating.

Exclusion Criteria

I have not been allergic to rifaximin or had a reaction to rifamycin, nor have I used rifaximin in the last 3 months.

My lung function is not severely reduced.

I have advanced liver disease or my liver tests are more than three times the normal limit.

Treatment Details

Interventions

• Placebo (Other)
• Rifaximin (Antibiotic)

Trial Overview The study tests Rifaximin, an FDA-approved antibiotic for IBS-related symptoms, against a placebo in treating gastrointestinal issues like bloating in cystic fibrosis patients. The goal is to enroll 100 participants into two groups: one receiving Rifaximin and the other a placebo.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Participants in this arm will receive Rifaximin 550 mg three times daily for 14 days.

Group II: Placebo Placebo Group 1 Intervention

Participants in this arm will receive placebo three times daily for 14 days.

Rifaximin is already approved in Canada, India for the following indications:

Approved in Canada as Zaxine 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?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School