Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2019-06-14
2025-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention Treatment
Subjects diagnosed with gastroparesis will receive Rifaximin
Rifaximin
550 mg by mouth three times daily for 14 days
Placebo Group
Subjects diagnosed with gastroparesis will receive a placebo
Placebo
By mouth three times daily for 14 days
Interventions
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Rifaximin
550 mg by mouth three times daily for 14 days
Placebo
By mouth three times daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Brian Lacy
Principal Investigator
Principal Investigators
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Brian E Lacy
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-002908
Identifier Type: -
Identifier Source: org_study_id
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