Rifaximin in Patients With Diabetic Gastroparesis

• Status: Recruiting
• Trial end date: 2021-09-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Rifaximin

Criteria

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.