Rifaximin in Patients With Diabetic Gastroparesis

Mayo Clinic

Status and phase: Suspended; Phase 2

Conditions: Diabetic Gastroparesis; Crohn Disease

Treatments: Drug: Rifaximin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04254549

19-002908

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Intervention Treatment

Experimental group

Description:

Subjects diagnosed with gastroparesis will receive Rifaximin

Treatment:

Drug: Rifaximin

Placebo Group

Placebo Comparator group

Description:

Subjects diagnosed with gastroparesis will receive a placebo

Treatment:

Drug: Placebo