Crohn Disease, Diabetic Gastroparesis
Conditions
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.
Interventions
DRUGRifaximin
550 mg by mouth three times daily for 14 days
DRUGPlacebo
By mouth three times daily for 14 days
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Bloating Based on Overall Questionnaire Scoring | From enrollment to end of treatment at 8 weeks. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian E Lacy
Mayo Clinic
Participant flow
Recruitment details
Patients were recruited through standard of care clinic appointments made with Dr. Lacy. Patients who saw him for treatment of gastroparesis and were seen as eligible were reached out to regarding participation.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Failure of Previous Medications | 4 Participants |
| Race/Ethnicity, Customized Ethnicity - Non Hispanic or Latino | 5 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 1 |
| other Total, other adverse events | 0 / 4 | 0 / 1 |
| serious Total, serious adverse events | 0 / 4 | 0 / 1 |
Outcome results
None listed