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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
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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:
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I have taken rifaximin within the last year.
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I do not have severe, uncontrolled anxiety or depression.
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My diabetes is not under control, with HgbA1c over 12.
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I have had surgery on my stomach or esophagus.
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I have a blockage in my digestive system.

Timeline

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
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Hyperkalaemia
2%
Bronchitis
2%
Peritonitis bacterial
2%
Liver transplant
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Non-cardiac chest pain
1%
Pneumonia
1%
Sepsis
1%
Fluid overload
1%
Hyperglycaemia
1%
Acute respiratory failure
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,324 Previous Clinical Trials
3,059,339 Total Patients Enrolled
Brian E LacyPrincipal InvestigatorMayo Clinic

Media Library

Rifaximin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04254549 — Phase 2
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Crohn's Disease Clinical Trial 2023: Rifaximin Highlights & Side Effects. Trial Name: NCT04254549 — Phase 2
Rifaximin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04254549 — Phase 2
~1 spots leftby Dec 2024