ClinicalTrials.Veeva

Menu

Rifaximin in Patients With Diabetic Gastroparesis

Mayo Clinic logo

Mayo Clinic

Status and phase

Suspended
Phase 2

Conditions

Diabetic Gastroparesis
Crohn Disease

Treatments

Drug: Rifaximin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04254549
19-002908

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Intervention Treatment
Experimental group
Description:
Subjects diagnosed with gastroparesis will receive Rifaximin
Treatment:
Drug: Rifaximin
Placebo Group
Placebo Comparator group
Description:
Subjects diagnosed with gastroparesis will receive a placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Central trial contact

Kristen Lozano

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems