Liver drug study pulled before it even started
NCT ID NCT04244877
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aimed to see if the antibiotic rifaximin could help people with liver cirrhosis who have a mild form of brain fog called covert hepatic encephalopathy, along with bacterial overgrowth in the gut. Researchers planned to give 40 patients rifaximin for eight weeks and test their thinking skills and gut function. However, the trial was withdrawn before enrolling anyone, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rifaximin (Xifaxan) tablet
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Started
-
Sep 2021
- Finished
-
Dec 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 89 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Cirrhosis patients between 18-89 years of age, without prior transjugular intrahepatic portosystemic shunt (TIPS) placement or prior overt hepatic encephalopathy. 2. Cirrhosis diagnosed on the basis of liver biopsy, liver stiffness measurement (Fibroscan) or radiological study. 3. CHE diagnosis using pre-defined criteria \[two of the following should be abnormal as compared to healthy controls: number connection test A/B (NCT-A/B), Digit Symbol Test (DST), or Block Design Test (BDT)\] at least 2 months prior to the start of the study (beyond 2 standard deviation of normal). Testing will be carried out by a trained psychologist. Exclusion Criteria: 1. Known allergy to rifaximin / rifabutin / rifampin. 2. Use of antibiotics within last 6 weeks 3. Use of lactulose / lactitol, probiotics, L-ornithine- L -aspartate, zinc, metronidazole, or neomycin, within last 6 weeks 4. Use of any drug known to affect gastro-intestinal motility within the previous 2 to 4 weeks (such as, Reglan, Erythromycin, or Domeperidone) 5. Use of drugs such as opiates and antidepressants (except stable doses of selective serotonin re-uptake inhibitors) 6. Patients deemed higher risk for capsule retention including a history of esophageal stricture or Zenker's diverticulum, partial or complete bowel obstruction, known fistulas, known large or numerous diverticula and dementia 7. Diseases associated with poor gastrointestinal motility such as uncontrolled diabetes (A1c \> 8%), rheumatological disorders (such as scleroderma and mixed connective tissue disorders \[MCT\]) 8. History of gastrointestinal tract or abdominal surgery 9. Spontaneous peritonitis or other severe infections 10. Colonoscopy or enema treatment within 4 weeks 11. Hepatic encephalopathy with clinical signs 12. Inability to complete neuropsychiatric testing due to hearing loss, poor vision, etc. 13. Poorly compliant patients 14. Rifaximin - Pregnancy Category C- There are no adequate and well controlled studies in pregnant women. Rifaximin has been shown to be teratogenic in rats and rabbits at doses that caused maternal toxicity. Female study subjects of childbearing potential must have a negative pregnancy test and agree to use an acceptable method of contraception throughout the study. Participants that are breastfeeding are excluded. 15. Decompensated cirrhosis (i.e., history of variceal bleeding or ascites) 16. Total bilirubin = 2mg/dL or albumin \< 3.5g/dL or international normalized ratio (INR) \> 1.7 17. Patients with a calculated glomerular filtration rate (GFR) \< 60mL/min/1.73m2 18. Patients with severe hepatic impairment (Child-Pugh score \> 7) 19. Patients with untreated viral hepatitis 20. No prior episode of overt HE, not on therapy for overt HE, not on any psycho- active medications apart from stable doses of selective serotonin re-uptake inhibitors. 21. No concurrent use of P-glycoprotein inhibitors (e.g., cyclosporine) 22. Current abuse of alcohol or illicit drugs
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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