Rifaximin in Patients With Diabetic Gastroparesis

Phase 2

Suspended

• Conditions: Crohn Disease; Diabetic Gastroparesis
• Interventions: Drug: Placebo; Drug: Rifaximin

• Registration Number: NCT04254549
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-14
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Status Verified: 2025-04
• Primary Completion: 2025-04-08
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects diagnosed with gastroparesis will receive a placebo
Intervention Treatment	Rifaximin	Subjects diagnosed with gastroparesis will receive Rifaximin

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States