Rifaximin for Bloating in Cystic Fibrosis

No longer recruiting at 1 trial location

Overseen By Jamie 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 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: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the antibiotic rifaximin can reduce bloating and other gastrointestinal symptoms in people with cystic fibrosis (CF). Participants will receive either rifaximin or a placebo to evaluate its effectiveness in easing these issues. Individuals with CF who frequently experience bloating or abdominal discomfort might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rifaximin is generally safe for people. In past studies, participants taking rifaximin experienced few side effects, mostly mild ones like nausea or headaches. This is encouraging for anyone considering joining a trial. Additionally, the FDA has approved rifaximin for treating certain gut issues, indicating its safety. Although it is not specifically approved for bloating related to cystic fibrosis, its approval for other stomach problems suggests it might be safe for this as well. While all treatments carry risks, current data on rifaximin indicates it is mostly safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bloating in cystic fibrosis?

Unlike the standard of care for bloating in cystic fibrosis, which typically involves dietary changes, enzyme supplements, and sometimes antibiotics, Rifaximin offers a targeted approach as a non-systemic antibiotic. It works directly in the gut to reduce bacterial overgrowth, which is believed to be a leading cause of bloating in these patients. Researchers are excited about Rifaximin because it acts locally in the intestines, minimizing systemic side effects, and has shown potential to provide relief in just 14 days of treatment. This makes it a promising option for those who need quicker and more focused symptom management.

What evidence suggests that rifaximin might be an effective treatment for bloating in cystic fibrosis?

Research shows that rifaximin can help with bloating and other stomach issues. One study found that 44.6% of patients who took rifaximin experienced improved bloating compared to those who didn’t. Another study demonstrated that rifaximin reduced symptoms like bloating and gas more effectively than a placebo. In this trial, participants in one arm will receive rifaximin, while those in another arm will receive a placebo. Rifaximin targets gut bacteria that might cause these symptoms. The FDA has already approved this antibiotic for treating irritable bowel syndrome (IBS), which supports its potential to help cystic fibrosis patients with bloating. ^{1 2 6 7 8}

Who Is on the Research Team?

Baha Moshiree, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Rifaximin

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.

How Is the Trial Designed?

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 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?

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+

Published Research Related to This Trial

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05408910

Rifaximin for Treatment of Bloating in Children and Adults ... This study aims to evaluate if this same-nonsystemically absorbed and noninvasive antibiotic can be used to treat similar commonly reported symptoms in people ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37310270/

Efficacy of Rifaximin in Patients With Abdominal Bloating or ... Rifaximin therapy led to a higher likelihood of improvement in symptoms of bloating (44.6% vs. 34.6%, RR 1.22, 95% CI 1.11, 1.35; n=2401 ...

3. ctv.veeva.com ctv.veeva.com/study/rifaximin-for-treatment-of-bloating-in-children-and-adults-with-cystic-fibrosis

Rifaximin for Treatment of Bloating in Children and Adults With ... Our small pilot study aims to investigate use of the only FDA-approved antibiotic, rifaximin for a GI syndrome- IBS, to treat bloating and global GI symptoms ...

4. cfdb.eu cfdb.eu/en/database/pdf/code/NCT05408910

Rifaximin for Treatment of Bloating in Children and Adults ... Cystic Fibrosis|Abdominal Pain|Small Bowel Disease - 12 Years and older ... Rifaximin Treatment Group Improvement of Symptoms|Improved ePROS scores.

5. withpower.com withpower.com/trial/phase-2-and-3-fibrosis-8-2022-a993b

Rifaximin for Bloating in Cystic Fibrosis In a randomized double-blind placebo-controlled trial with 124 patients, rifaximin significantly improved symptoms of bloating and flatulence compared to ...

6. cfdb.eu cfdb.eu/en/database/article/code/NCT05408910

Rifaximin for Treatment of Bloating in Children and Adults ... CFDB - Cystic Fibrosis DataBase · Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis - Phase 2|Phase 3 - Not yet recruiting.

7. go.drugbank.com go.drugbank.com/drugs/DB01220

Rifaximin: Uses, Interactions, Mechanism of Action Improve decision support & research outcomes with our structured adverse effects data. ... Abdominal Pain / Cystic Fibrosis (CF) / Small Bowel Diseases · 1 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8533823/

Efficacy and Safety of Rifaximin Versus Placebo or Other ... Our results demonstrated that rifaximin had a significant beneficial effect on improvement of OHE, reversal of MHE, and prevention of recurrent ...