Trial Outcomes & Findings for Rifaximin in Patients With Diabetic Gastroparesis (NCT NCT04254549)

Last Updated: 2026-06-22

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

From enrollment to end of treatment at 8 weeks.

Results posted on

2026-06-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Intervention Treatment Subjects diagnosed with gastroparesis will receive Rifaximin	Placebo Group Subjects diagnosed with gastroparesis will receive a placebo
Overall Study STARTED	4	1
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patients were grouped randomly by pharmacy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Treatment n=4 Participants Subjects diagnosed with gastroparesis will receive Rifaximin	Placebo Group n=1 Participants Subjects diagnosed with gastroparesis will receive a placebo	Total n=5 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	2 Participants n=20 Participants	1 Participants n=20 Participants	3 Participants n=40 Participants • Patients were grouped randomly by pharmacy
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical >=65 years	2 Participants n=20 Participants	0 Participants n=20 Participants	2 Participants n=40 Participants
Sex: Female, Male Female	3 Participants n=20 Participants	1 Participants n=20 Participants	4 Participants n=40 Participants
Sex: Female, Male Male	1 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants
Race/Ethnicity, Customized Ethnicity - Non Hispanic or Latino	4 Participants n=20 Participants	1 Participants n=20 Participants	5 Participants n=40 Participants
Region of Enrollment United States	4 Participants n=20 Participants	1 Participants n=20 Participants	5 Participants n=40 Participants
Failure of Previous Medications	4 Participants n=20 Participants	1 Participants n=20 Participants	5 Participants n=40 Participants

PRIMARY outcome

Timeframe: From enrollment to end of treatment at 8 weeks.

Outcome measures

Outcome measures
Measure	Intervention Treatment n=4 Participants Subjects diagnosed with gastroparesis will receive Rifaximin	Placebo Group n=1 Participants Subjects diagnosed with gastroparesis will receive a placebo
Improvement in Bloating Based on Overall Questionnaire Scoring	4 participants	1 participants

Adverse Events

Intervention Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian E. Lacy

Mayo Clinic Florida

Phone: 904-953-3576

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place