Rifaximin in Patients With Diabetic Gastroparesis

NCT04254549 | Terminated Phase 2 FDA Drug

• 1 other identifier: 19-002908
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Improvement in bloating

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

  Week 2, week 4, week 8

Study Arms (2)

Intervention Treatment

EXPERIMENTAL

Subjects diagnosed with gastroparesis will receive Rifaximin

Drug: Rifaximin

Placebo Group

PLACEBO COMPARATOR

Subjects diagnosed with gastroparesis will receive a placebo

Drug: Placebo

Interventions

Rifaximin DRUG

550 mg by mouth three times daily for 14 days

Also known as: TD-1473

Intervention Treatment

Placebo DRUG

By mouth three times daily for 14 days

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Crohn Disease

Interventions

Rifaximin; izencitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Brian E Lacy

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: June 14, 2019
• Primary Completion: April 8, 2025
• Study Completion: April 11, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)