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Rifaximin in Patients With Diabetic Gastroparesis

Primary Purpose

Crohn Disease, Diabetic Gastroparesis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rifaximin

Placebo

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic in FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Treatment

Placebo Group

Arm Description

Subjects diagnosed with gastroparesis will receive Rifaximin

Subjects diagnosed with gastroparesis will receive a placebo

Outcomes

Primary Outcome Measures

Improvement in bloating

Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention

Secondary Outcome Measures

Full Information

NCT ID

NCT04254549

First Posted

February 3, 2020

Last Updated

December 12, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04254549

Brief Title

Rifaximin in Patients With Diabetic Gastroparesis

Official Title

Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 14, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, Diabetic Gastroparesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Treatment

Arm Type

Experimental

Arm Description

Subjects diagnosed with gastroparesis will receive Rifaximin

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Subjects diagnosed with gastroparesis will receive a placebo

Intervention Type

Drug

Intervention Name(s)

Rifaximin

Other Intervention Name(s)

TD-1473

Intervention Description

550 mg by mouth three times daily for 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

By mouth three times daily for 14 days

Primary Outcome Measure Information:

Title

Improvement in bloating

Description

Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention

Time Frame

Week 2, week 4, week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian E Lacy

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian Lacy, MD

Phone

904-953-2000

lacy.brian@mayo.edu

First Name & Middle Initial & Last Name & Degree

Cangemi David, MD

Phone

904-953-2000

cangemi.david@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Rifaximin in Patients With Diabetic Gastroparesis

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