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NCT04254549 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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