Rifaximin in Patients With Diabetic Gastroparesis

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254549
• Other study ID #: 19-002908
• Status: Recruiting
• Phase: Phase 2
• Start date: June 14, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• Rifaximin
550 mg by mouth three times daily for 14 days
• Placebo
By mouth three times daily for 14 days

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials