A Study to Evaluate the Therapeutic Effectiveness of Rifaximin in Diabetic Gastroparesis Patients Using Bloating as the Primary Endpoint

Overview

About this study

The primary purpose of this study is to prospectively assess symptoms of bloating (severity, prevalence) in patients with diabetic gastroparesis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Men and women adult patients, aged 18-75 years old.
  • Adult patients with diabetic gastroparesis.
  • Patients will be recruited from the GI clinic, general medical clinic and the community.
  • The 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Brian Lacy, M.D., Ph.D.

Open for enrollment

Contact information:

Thomas Morse

Morse.Thomas@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20463724

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