Rifaximin in Patients With Diabetic Gastroparesis

NCT04254549 | Terminated Phase 2 Results 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 Based on Overall Questionnaire Scoring

  Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention. Questionnaires used are the Quality of Life SF-36v2 Survey, Gastroparesis Cardinal Symptom Index Daily Diary, Hospital Anxiety and Depression Scale, and Nepean Dyspepsia Index.

  From enrollment to end of treatment at 8 weeks.

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

Limitations and Caveats

Some limitations included finding patients who were the correct diagnosis and without any exclusion criteria. Due to needing medication, patients also needed to be able to come to clinic if they were not local to Jacksonville. This caused some limitations on which patients were willing to make the journey.

Results Point of Contact

• Title: Dr. Brian E. Lacy
• Organization: Mayo Clinic Florida

lacy.brian@mayo.edu

904-953-3576

Study Officials

• Brian E Lacy

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)