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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, week 4, week 8
Awards & highlights

Study Summary

This trial is testing whether a certain antibiotic can help relieve symptoms of bloating for people with diabetic gastroparesis.

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).Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Gastrointestinal haemorrhage
1%
Acute respiratory failure
1%
Haematemesis
1%
Hyperglycaemia
1%
Fluid overload
1%
Non-cardiac chest pain
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,998 Total Patients Enrolled
9 Trials studying Gastroparesis
587 Patients Enrolled for Gastroparesis
Brian E LacyPrincipal InvestigatorMayo Clinic

Media Library

Rifaximin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04254549 — Phase 2
Gastroparesis Research Study Groups: Placebo Group, Intervention Treatment
Gastroparesis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Mayo Clinic in Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Rifaximin in Patients With Diabetic Gastroparesis
Brian Lacy 2019. "Rifaximin in Patients With Diabetic Gastroparesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04254549.
All > Diabetic Gastroparesis > Gastroparesis
~4 spots leftby Dec 2024
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