Rifaximin in Patients With Diabetic Gastroparesis

Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.

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.

Study Overview

• Status: Terminated
• Conditions: Crohn Disease; Diabetic Gastroparesis
• Intervention / Treatment: Drug: Rifaximin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Treatment; Subjects diagnosed with gastroparesis will receive Rifaximin	Drug: Rifaximin; 550 mg by mouth three times daily for 14 days; Other Names: TD-1473
Placebo Comparator: Placebo Group; Subjects diagnosed with gastroparesis will receive a placebo	Drug: Placebo; By mouth three times daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in bloating	Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention	Week 2, week 4, week 8

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brian E Lacy, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Actual): April 8, 2025
• Study Completion (Actual): April 11, 2025

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Rifamycins; Lactams, Macrocyclic; Macrocyclic Compounds; Rifaximin; izencitinib
• Other Study ID Numbers: 19-002908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No