NCT04254549TerminatedPhase 2
Rifaximin in Patients With Diabetic Gastroparesis
Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Reason given: Sponsor discontinued placebo. Unable to meet enrollment goals.
Brief summary (registry, in English)
Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 3 Feb 2020
- Start date
- 14 Jun 2019
- Primary completion date
- 8 Apr 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- Crohn's disease
- NCT number
- NCT04254549
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior surgery to the stomach or esophagus
- Prior treatment with rifaximin (< 1 year)
Other illness
- Uncontrolled diabetes with a HgbA1c > 12
Other
- Known mechanical obstruction of the GI tract
- Current or recent (< 4 weeks) use of opioids
- Current/active use of cannabis
- Current or recent (< 4 weeks) use of antibiotics
- Current or recent use of antifungal agents (< 4 weeks)
- Severe uncontrolled or untreated anxiety or depression.
Who the study is looking for
- Men and women adult patients, aged 18-75, with diabetic gastroparesis
- Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; > 20% remaining at 4 hours)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.