Rifaximin in Patients with Diabetic Gastroparesis

Last updated: January 18, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

2

Condition

Gastroparesis

Diabetic Gastroparesis

Treatment

Rifaximin

Placebo

Clinical Study ID

NCT04254549
19-002908
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Rifaximin
Phase: 2
Study Start date:
June 14, 2019
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

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