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Rifaximin in Patients With Diabetic Gastroparesis

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04254549
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
41.6
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.
Actual Study Start Date :
Jun 14, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Treatment

Subjects diagnosed with gastroparesis will receive Rifaximin

Drug: Rifaximin
550 mg by mouth three times daily for 14 days
Other Names:
  • TD-1473

    		•
    Placebo Comparator: Placebo Group

    Subjects diagnosed with gastroparesis will receive a placebo

    Drug: Placebo
    By mouth three times daily for 14 days

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Brian E Lacy, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Brian E. Lacy, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04254549
    Other Study ID Numbers:
    • 19-002908
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease
    Gastroparesis
    Rifaximin

    Study Results

    No Results Posted as of Dec 8, 2021