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Rifaximin for Treatment of Bloating in Children and Adults With Cystic Fibrosis

NCT05408910 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2025-06-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Rifaximin 550 MG Oral Tablet [XIFAXAN]

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Baha Moshiree, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408910 on ClinicalTrials.gov