- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254549
Rifaximin in Patients With Diabetic Gastroparesis
December 13, 2023 updated by: Brian Lacy, Mayo Clinic
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Recruiting
- Mayo Clinic in Florida
-
Contact:
- Brian Lacy, MD
- Phone Number: 904-953-2000
- Email: lacy.brian@mayo.edu
-
Contact:
- Cangemi David, MD
- Phone Number: 904-953-2000
- Email: cangemi.david@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Treatment
Subjects diagnosed with gastroparesis will receive Rifaximin
|
550 mg by mouth three times daily for 14 days
Other Names:
|
Placebo Comparator: Placebo Group
Subjects diagnosed with gastroparesis will receive a 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
Time Frame: Week 2, week 4, week 8
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian E Lacy, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2019
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
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)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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