What is the mechanism of action of this treatment?

Common treatments for gastroparesis primarily aim to enhance gastric motility and alleviate symptoms such as nausea, vomiting, and bloating. Prokinetic agents like metoclopramide and domperidone increase gastric emptying by stimulating muscle contractions in the stomach. Antibiotics like rifaximin, which alter gut microbiota, can reduce bloating and discomfort by decreasing bacterial overgrowth in the small intestine. These treatments are crucial for gastroparesis patients as they address the underlying motility issues and symptomatic relief, improving overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for gastroparesis include metoclopramide, domperidone, erythromycin, and cisapride. Metoclopramide can cause side effects such as tardive dyskinesia, drowsiness, and fatigue. Domperidone may lead to cardiac arrhythmias and increased prolactin levels. Erythromycin can cause gastrointestinal disturbances like nausea and abdominal pain. Cisapride, though less commonly used, is associated with serious cardiac side effects, including arrhythmias. Rifaximin, an antibiotic studied for altering gut microbiota to reduce bloating, generally has mild side effects such as nausea, dizziness, and fatigue.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of gastroparesis, primarily focusing on prokinetic agents that enhance gastric emptying. Metoclopramide is the most commonly used and FDA-approved prokinetic for gastroparesis. Domperidone and erythromycin are also used, although domperidone is not FDA-approved and erythromycin is typically used off-label. These treatments do not specifically alter gut microbiota like Rifaximin, which is being studied for its potential to reduce bloating symptoms by modifying gut flora. Other treatments for gastroparesis include antiemetics and, in refractory cases, interventions like jejunal feeding tubes or venting gastrostomy tubes.

What other types of research exist?

Promising alternatives to Rifaximin for gastroparesis patients include rikkunshito, an herbal medicine with prokinetic and non-prokinetic effects, and acotiamide, a prokinetic drug used for functional dyspepsia.

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Antibiotic

Rifaximin for Gastroparesis

Phase 2

Recruiting

Led By Brian E Lacy

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Must not have

Prior treatment with rifaximin (< 1 year)

Severe uncontrolled or untreated anxiety or depression.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, week 4, week 8

Summary

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.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

Rifaximin may cause side effects such as digestive issues like nausea and diarrhea. It could also potentially lead to headaches or dizziness. The exact side effects for this trial aren't listed but these are common ones associated with rifaximin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have taken rifaximin within the last year.

Select...

I do not have severe, uncontrolled anxiety or depression.

Select...

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

Select...

I have had surgery on my stomach or esophagus.

Select...

I have a blockage in my digestive system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, week 4, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, week 4, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 4, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in bloating

Side effects data

From 2014 Phase 4 trial • 222 Patients • NCT01842581

19%

Hepatic encephalopathy

17%

Oedema peripheral

16%

Constipation

14%

Nausea

14%

Fatigue

12%

Insomnia

11%

Urinary tract infection

10%

Pruritus generalised

Muscle spasms

Abdominal pain

Decreased appetite

Ascites

Dyspnoea

Headache

Cough

Renal failure acute

Vomiting

Asthenia

Anaemia

Anxiety

Jaundice

Diarrhoea

Abdominal distension

Cellulitis

Depression

Hyperkalaemia

Bronchitis

Peritonitis bacterial

Liver transplant

Gastrointestinal haemorrhage

Haematemesis

Non-cardiac chest pain

Pneumonia

Sepsis

Fluid overload

Hyperglycaemia

Acute respiratory failure

Herpes zoster

Cerebrovascular accident

Thrombocytopenia

Pneumococcal bacteraemia

Septic shock

Craniocerebral injury

Hepatic failure

Hepatitis

Hepatorenal syndrome

Toxic encephalopathy

Subarachnoid haemorrhage

Anxiety disorder

Suicidal ideation

Calculus ureteric

Oliguria

Renal failure

Pleural effusion

Flatulence

Cardiac failure congestive

Haematochezia

Upper gastrointestinal haemorrhage

Chest pain

Systemic inflammatory response syndrome

Chronic hepatic failure

Subdural haematoma

Dehydration

Alcoholic seizure

Hypovolaemic shock

100%

80%

60%

40%

20%

Study treatment Arm

Rifaximin 550 mg BID

Rifaximin 550 mg BID + Lactulose

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rifaximin

2005

Completed Phase 4

~3120

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastroparesis primarily aim to enhance gastric motility and alleviate symptoms such as nausea, vomiting, and bloating. Prokinetic agents like metoclopramide and domperidone increase gastric emptying by stimulating muscle contractions in the stomach. Antibiotics like rifaximin, which alter gut microbiota, can reduce bloating and discomfort by decreasing bacterial overgrowth in the small intestine. These treatments are crucial for gastroparesis patients as they address the underlying motility issues and symptomatic relief, improving overall quality of life.

Effect of a low-flatulogenic diet in patients with flatulence and functional digestive symptoms.