Rifaximin for Gastroparesis

Palo Alto (17 mi)

Overseen byBrian E Lacy

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mayo Clinic

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing whether rifaximin can help people with diabetic gastroparesis who have bloating. Rifaximin is an antibiotic that reduces bacteria in the gut. By lowering these bacteria, it may help reduce bloating symptoms.

Eligibility Criteria

Adults aged 18-75 with diabetic gastroparesis, previously diagnosed by symptoms and delayed gastric emptying, can join this trial. Excluded are those with prior stomach surgery, GI obstruction, recent opioid or antibiotic use, untreated severe anxiety or depression, active cannabis use, recent antifungal treatment, rifaximin treatment within the last year or uncontrolled diabetes (HgbA1c > 12).

Inclusion Criteria

I have been diagnosed with diabetic gastroparesis based on specific symptoms and tests.

Exclusion Criteria

I have taken rifaximin within the last year.

I do not have severe, uncontrolled anxiety or depression.

My diabetes is not under control, with HgbA1c over 12.

I have had surgery on my stomach or esophagus.

I have a blockage in my digestive system.

Treatment Details

The study is testing if rifaximin improves bloating in patients with diabetic gastroparesis compared to a placebo. Participants will be randomly assigned to receive either the medication or an inactive substance.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention TreatmentExperimental Treatment1 Intervention

Subjects diagnosed with gastroparesis will receive Rifaximin

Group II: Placebo GroupPlacebo Group1 Intervention

Subjects diagnosed with gastroparesis will receive a placebo

Rifaximin is already approved in United States, Canada, European Union, India for the following indications:

🇺🇸 Approved in United States as Xifaxan for: