Rifaximin in Patients With Diabetic Gastroparesis (NCT04254549) | Clinical Trial Compass
TerminatedPhase 2
Rifaximin in Patients With Diabetic Gastroparesis
Stopped: Sponsor discontinued placebo. Unable to meet enrollment goals.
United States5 participantsStarted 2019-06-14
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria
* 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)
Exclusion Criteria
* Prior surgery to the stomach or esophagus
* 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)
* Prior treatment with rifaximin (\< 1 year)
* Uncontrolled diabetes with a HgbA1c \> 12
* Severe uncontrolled or untreated anxiety or depression.