Sponsor discontinued placebo. Unable to meet enrollment goals.

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.

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.

From enrollment to the end of the 8 week study or patient early withdrawal.

This study is a minimal risk study using a known and proven safe drug. The drug is being used off label. Adverse events were minimal and are the same definition as Clinical Trials

Some limitations included finding patients who were the correct diagnosis and without any exclusion criteria. Due to needing medication, patients also needed to be able to come to clinic if they were not local to Jacksonville. This caused some limitations on which patients were willing to make the journey.