- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05408910
Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis
Gastrointestinal symptoms are commonly reported in as much as 65% of people with CF even independent of pancreatic enzyme replacement therapy (PERT) and the most frequent of these symptoms are bloating/distension, flatulence, abdominal pain and bowel habit changes. An alteration in the intestinal microbiome due to intestinal dysmotility, inflammation or other changes including pH changes in the intestine related to CFTR gene mutation may cause intestinal dysbiosis leading to a bacterial overgrowth in the proximal small intestine which may explain some of the findings of distension and bloating in CF.
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 in CF patients with bloating and distension. Our goal is to recruit patients >12 years and age/sex matched into rifaximin and placebo arms with total of 100 recruited subjects recruited.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Baha Moshiree, MD
- Phone Number: 704-355-0244
- Email: bmoshire@wakehealth.edu
Study Contact Backup
- Name: Jamie Crawford, BSN
- Phone Number: 704-355-0282
- Email: jamie.crawford@atriumhealth.org
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Atrium Health
-
Contact:
- Jamie Crawford, BSN
- Phone Number: 704-355-0282
- Email: jamie.crawford@atriumhealth.org
-
Contact:
- Katelyn Glen, BS
- Phone Number: 704.355.0282
- Email: katelyn.glen@atriumhealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed CF diagnosis who are enrolled in the CFF registry.
- Mild to severe symptom severity defined as abdominal Distention score ≥ 2 and/or bloating score ≥ 2 on a Likert Scale of 0-6)
- Patient age ≥12 years and ≥ 30 kilograms (~66.15 lbs)
- Ability to provide informed consent or presence of legally authorized representative (LAR)
- Ability to take drug or placebo by mouth (Pill must be intact. May not be opened, crushed, or modified to aid in ingestion)
Exclusion Criteria:
- Subjects who have previously been allergic to rifaximin or had a hypersensitivity to rifamycin or used rifaximin for any reason within three months (12 weeks) of the study start date
- Subjects with FEV1 < 40 (as measured within the last 12 months) will be excluded from the study given potential risks in subjects with advanced lung disease
- Subjects who have received a new antibiotic for treatment of an acute pulmonary infection, or antibiotics for any other infection within 4 weeks prior to randomization or during the study period. Cyclic Antibiotics- Inhaled cyclic antibiotics are allowed at any timepoint. Oral or systemic cyclic antibiotics are exclusionary except for prophylactic antibiotics (e.g., azithromycin) which are allowed. New prophylactic antibiotics cannot be started within 4 weeks of randomization.
- Subjects with a recent pulmonary exacerbation defined as 4 weeks prior to screening will not be enrolled
- Subjects who are on probiotics will be asked to discontinue the use of probiotics 14 days prior to randomization as probiotics can alter the gut microbiome and cause bloating
- Subjects with newly initiated cystic fibrosis transmembrane conductance regulator (CFTR) modulator treatments within one month prior to the study
- Subjects with new onset of distal intestinal obstruction syndrome (DIOS) or constipation
Subjects with advanced liver disease defined by:
- portal hypertension and/or child Pugh B or C cirrhosis
- or those with elevated liver enzymes-both AST/ALT > 3 times the upper limit of normal at screening
- Subjects with bilirubin or alkaline phosphatase elevations > 2 times the upper limit of normal at screening will be excluded as this may be related to CFTR modulator use
- Women of childbearing potential who are pregnant, trying to become pregnant, breastfeeding, or not using an acceptable method of contraception as described in Section 6.2.
- Known clostridium difficile colitis. Colonization with c. difficile is not exclusionary.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Participants in this arm will receive Rifaximin 550 mg three times daily for 14 days.
|
Participants in this arm will receive Rifaximin 550 mg three times daily for 14 days.
|
Placebo Comparator: Placebo
Participants in this arm will receive placebo three times daily for 14 days.
|
Participants in this arm will receive placebo three times daily for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rifaximin Treatment Group Improvement of Symptoms
Time Frame: Two weeks
|
The primary aim and outcome of our study is to show a significant improvement in individual symptoms of abdominal bloating and/or distension, in PwCF (People with Cystic Fibrosis) treated with rifaximin as compared to placebo
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved ePROS scores
Time Frame: 42 days
|
Our secondary aim and outcome will be based on improvements in the overall ePROS scores and sub-scores for bloating and distension as obtained from GALAXY.
These questionnaires will be on a Likert scale ranging from 0-6 where 0 is "Not at all" and 6 is "A very great deal"
|
42 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Baha Moshiree, MD, Wake Forest University Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Pancreatic Diseases
- Fibrosis
- Abdominal Pain
- Cystic Fibrosis
- Anti-Infective Agents
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Rifaximin
Other Study ID Numbers
- IRB00086338
- MOSHIR21-A0-I (Other Identifier: Atrium Health)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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