Rifaximin for Gastroparesis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Florida, Jacksonville, FLGastroparesis+1 MoreRifaximin - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Diabetic Gastroparesis
  • Crohn's Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Week 2, week 4, week 8

Week 8
Improvement in bloating

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Rifaximin 550 mg BID
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%Headache
6%Dyspnoea
5%Renal failure acute
5%Anaemia
5%Vomiting
5%Asthenia
5%Anxiety
5%Cough
4%Diarrhoea
4%Jaundice
3%Cellulitis
3%Abdominal distension
3%Depression
2%Peritonitis bacterial
2%Bronchitis
2%Hyperkalaemia
2%Liver transplant
1%Septic shock
1%Non-cardiac chest pain
1%Sepsis
1%Pneumococcal bacteraemia
1%Pneumonia
1%Chest pain
1%Thrombocytopenia
1%Cardiac failure congestive
1%Gastrointestinal haemorrhage
1%Haematemesis
1%Haematochezia
1%Upper gastrointestinal haemorrhage
1%Systemic inflammatory response syndrome
1%Chronic hepatic failure
1%Hepatic failure
1%Hepatitis
1%Hepatorenal syndrome
1%Herpes zoster
1%Craniocerebral injury
1%Subdural haematoma
1%Dehydration
1%Fluid overload
1%Hyperglycaemia
1%Alcoholic seizure
1%Cerebrovascular accident
1%Subarachnoid haemorrhage
1%Toxic encephalopathy
1%Anxiety disorder
1%Suicidal ideation
1%Calculus ureteric
1%Oliguria
1%Renal failure
1%Acute respiratory failure
1%Pleural effusion
1%Hypovolaemic shock
1%Flatulence
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01842581) in the Rifaximin 550 mg BID ARM group. Side effects include: Hepatic encephalopathy with 19%, Oedema peripheral with 17%, Constipation with 16%, Nausea with 14%, Fatigue with 14%.

Trial Design

2 Treatment Groups

Intervention Treatment
1 of 2
Placebo Group
1 of 2

Experimental Treatment

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Rifaximin · Has Placebo Group · Phase 2

Intervention Treatment
Drug
Experimental Group · 1 Intervention: Rifaximin · Intervention Types: Drug
Placebo Group
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Izencitinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 2, week 4, week 8

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,958 Previous Clinical Trials
3,449,393 Total Patients Enrolled
7 Trials studying Gastroparesis
195 Patients Enrolled for Gastroparesis
Brian E LacyPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18 - 75 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are an adult between the ages of 18 and 75 and have a condition called diabetic gastroparesis.