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Trial record 2 of 4 for:    brian lacy

Rifaximin in Patients With Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254549
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Brian E. Lacy, Mayo Clinic

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
Crohn Disease Diabetic Gastroparesis Drug: Rifaximin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 14, 2019
Estimated Primary Completion Date : June 14, 2020
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

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 Name: TD-1473

Placebo Comparator: Placebo Group
Subjects diagnosed with gastroparesis will receive a placebo
Drug: Placebo
By mouth three times daily for 14 days




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254549


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Brian Lacy, MD    904-953-2000    lacy.brian@mayo.edu   
Contact: Cangemi David, MD    904-953-2000    cangemi.david@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Brian E Lacy Mayo Clinic

Additional Information:
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Responsible Party: Brian E. Lacy, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04254549    
Other Study ID Numbers: 19-002908
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Gastroparesis
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents