Rifaximin for Gastroparesis

Recruiting in Palo Alto (17 mi)

Overseen by Brian E Lacy

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Mayo Clinic

Must not be taking: Opioids, Cannabis, Antibiotics, Antifungals

Disqualifiers: Stomach surgery, GI obstruction, others

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you have used opioids, cannabis, antibiotics, or antifungal agents in the past 4 weeks.

Is Rifaximin safe for human use?

Rifaximin is generally considered safe for human use, with studies showing it is poorly absorbed in the body, which limits side effects. In trials, any adverse events were not serious and not related to the medication. ^{1 2 3 4 5}

How does the drug Rifaximin differ from other treatments for gastroparesis?

Rifaximin is unique because it is an antibiotic that targets gut bacteria, which may help reduce symptoms of gastroparesis by altering the gut microbiome, unlike other treatments that primarily focus on enhancing stomach motility. ^{6 7 8 9 10}

Research Team

Brian E Lacy

Principal Investigator

Mayo Clinic

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.

I am between 18 and 75 years old with diabetic gastroparesis.

Exclusion Criteria

I have not used antifungal agents in the last 4 weeks.

I have taken antibiotics within the last 4 weeks.

You are currently using cannabis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rifaximin or placebo for diabetic gastroparesis

8 weeks

Visits at week 2, week 4, and week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo (Other)
• Rifaximin (Antibiotic)

Trial Overview 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.

Participant Groups

Group I: Intervention Treatment Experimental Treatment 1 Intervention

Subjects diagnosed with gastroparesis will receive Rifaximin

Group II: Placebo Group Placebo Group 1 Intervention

Subjects diagnosed with gastroparesis will receive a placebo

Rifaximin is already approved in Canada, India for the following indications:

Approved in Canada as Zaxine for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Approved in India as Ciboz and Xifapill for:

• Traveler's diarrhea
• Irritable bowel syndrome with diarrhea
• Hepatic encephalopathy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Florida Jacksonville, FL

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

References

1. United States pubmed.ncbi.nlm.nih.gov

Rifaximin: a nonabsorbed oral antibiotic. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Rifaximin: a novel nonabsorbed rifamycin for gastrointestinal disorders. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Does low-dose rifaximin ameliorate endotoxemia in patients with liver cirrhosis: a prospective study. [2018]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of rifaximin compared with ciprofloxacin for the treatment of acute infectious diarrhea: a randomized controlled multicenter study. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Is generic rifaximin still a poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy volunteers. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis. [2012]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison between the effects of neostigmine and ranitidine on interdigestive gastroduodenal motility of patients with gastroparesis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial: a controlled pilot trial of the 5-HT4 receptor agonist revexepride in patients with symptoms suggestive of gastroparesis. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Mirtazapine for severe gastroparesis unresponsive to conventional prokinetic treatment. [2018]

10. Pakistan pubmed.ncbi.nlm.nih.gov

Ranitidine Can Potentiate The Prokinetic Effect Of Itopride At Low Doses- An In Vitro Study. [2018]