Apply to Trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

100 Participants Needed

Rifaximin for Bloating in Cystic Fibrosis

Recruiting at 1 trial location

Overseen ByJamie Crawford, BSN

Age: Any Age

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Wake Forest University Health Sciences

Must not be taking: Oral antibiotics

Disqualifiers: Advanced lung disease, Advanced liver disease, Pregnancy, others

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 6 JurisdictionsThis treatment is already approved in other countries

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).

Will I have to stop taking my current medications?

The trial requires that you stop taking probiotics 14 days before starting the study. If you are on oral or systemic cyclic antibiotics, you cannot participate unless they are prophylactic antibiotics like azithromycin. New antibiotics for infections cannot be started within 4 weeks of the study.

How is the drug Rifaximin unique for treating bloating in cystic fibrosis?

Rifaximin is unique because it is a nonabsorbable antibiotic that stays in the gut, making it effective for treating bloating by targeting bacterial overgrowth in the intestines, which is common in cystic fibrosis patients.¹ ² ³ ⁴ ⁵

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.

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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.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rifaximin 550 mg or placebo three times daily for 14 days

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

Placebo
Rifaximin

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Findings from Research

In a randomized double-blind placebo-controlled trial with 124 patients, rifaximin significantly improved symptoms of bloating and flatulence compared to placebo, with 41.3% of patients reporting relief versus 22.9% in the placebo group after treatment.

Rifaximin was found to be safe, with no reported adverse events, and its efficacy was particularly noted in patients with irritable bowel syndrome (IBS), where symptom improvement correlated with a significant reduction in H2-breath excretion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized double-blind placebo-controlled trial of rifaximin in patients with abdominal bloating and flatulence.Sharara, AI., Aoun, E., Abdul-Baki, H., et al.[2022]

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]