Liver CirrhosisPhase 4NCT01842113
Quality of Life and Nutritional Improvements in Cirrhotic Patients
A Phase 4 study testing Rifaximin and Lactulose in people with Liver Cirrhosis and Hepatic Encephalopathy, run by Tampa General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction with the use of nutritional concepts is effective in improving morbidity and quality of life in cirrhotic patients suffering from hepatic encephalopathy (HE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatic Encephalopathy, Portal Hypertension
- What is being tested?
- Rifaximin and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female gender of Age 18 years or older
- Liver cirrhosis defined as one or more of the following: Radio-graphically proven portal hypertension (CT with nodular appearance) or Liver biopsy with cirrhosis
- Model for End Stage Liver Disease (MELD) score < 20
- Willingness to provide written informed consent, and participate in all study requirements
- Sodium greater than 130 meq/L
- Conn Score < 2
Who cannot join
- Active alcohol consumption
- Serum total bilirubin level > 5 mg/dl
- History of hepatocellular carcinoma (HCC) and malignancies other than basal cell carcinoma of the skin
- Pregnant or breastfeeding women
- Subject has renal insufficiency requiring routine dialysis
- Poorly controlled diabetes as defined by HgA1C > 10
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- Narcotic/psychotropic usage other than a stable dose of antidepressant and/or methadone. Neurontin (gabapentin) and Lyrica (pregabalin) are permitted if the subject has been on a stable dose for at least 2 months prior to the screening visit and no change of dosing is expected throughout the length of the trial
- Any of the following diagnoses:
- HIV
- Evidence of severe concomitant illness or any condition that makes them unsuitable for the study in the opinion of the investigator(s)
- Subject has received an investigational drug within 30 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Nutritional Improvements in Cirrhotic Patients Following Hepatic Encephalopathy Using Rifaximin.
The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction with the use of nutritional concepts is effective in improving morbidity and quality of life in cirrhotic patients suffering from hepatic encephalopathy (HE).
Read the detailed description
Prevention of portal hypertension complications should be at the forefront. In doing so, the end result will be an improvement in the multitude of morbidity and mortality issues. The proposed prospective trial will compare patients with similar demographics and medical and clinical settings utilizing standard of care therapy. Study subjects will be randomly assigned into two treatment groups. Group one will receive Lactulose 30ml three times a day as SOC and Rifaximin Placebo 550mg twice a day with nutritional supervision and group two will receive Rifaximin 550mg twice per day as SOC and Lactulose placebo 30ml three times per day with nutritional supervision.
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy, Portal Hypertension
- Being tested
- Rifaximin, Lactulose, Lactulose Placebo, Rifaximin Placebo
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Xifaxan
Rifaximin 550mg by mouth twice a day
LactuloseDrug
Also called Enulose, Generlac, Cholac, Constulose
Lactulose 30ml by mouth three times a day
Lactulose PlaceboDrug
Lactulose Placebo 30ml three times a day
Rifaximin PlaceboDrug
Also called Sugar Pill
Rifaximin Placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| Lactulose and Rifaximin Placebo | Active comparator | Standard portal hypertension care, standard nutritional advice, Lactulose 30ml three times a day and Rifaximin (Xifaxan) Placebo twice a day. Receives: Drug: Lactulose; Drug: Rifaximin Placebo |
| Rifaximin and Lactulose Placebo | Active comparator | Rifaximin (Xifaxan) twice a day and Lactulose Placebo three times a day. Receives: Drug: Rifaximin; Drug: Lactulose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of Change in Quality of Life Assessment Between the Two Groups
Quality of Life will be determined by the Chronic Liver Disease Foundation Questionnaire (CLDQ), the Sleep Scale by Hays, R.D.\&Stewart, A.L. and the Multidimensional Assessment of Fatigue (MAF) Scale and measured based upon Subjective Global Assessment (SGA).
Measured: Participants will be followed for 180 days
Nutritional Improvement Between the Two Groups
These outcomes will be determined as Body Composition Analysis via the Quadscan 4000 BIA device manufactured by Bodystat;calories burned, steps taken and levels of physical activity to sleep efficiency will be measured via the Bodymedia CORE Fit actigraph device and various standard of care laboratories.
Measured: Participants will be followed for 180 days
Secondary outcomes (1)
Markers of improvement in general health
These outcomes will be determined as Body Composition Analysis via the Quadscan 4000 BIA device manufactured by Bodystat;calories burned, steps taken and levels of physical activity to sleep efficiency will be measured via the Bodymedia CORE Fit actigraph device and various standard of care laboratories.
Measured: Participants will be followed for 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2014 (estimated)
Why it stopped: PI Initiated study - PI left facility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Neff, MD, Tampa General Hospital
- Investigators
- Guy Neff, MD, MBA, Principal investigator, Tampa General Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842113
- Sponsor's protocol ID
- Rifaximin and Nutrition
- Status last verified
- Sep 2013
- First submitted
- 11 Apr 2013
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Nutritional Improvements in Cirrhotic Patients Following Hepatic Encephalopathy Using Rifaximin.
- ClinicalTrials.gov ID
- NCT01842113
- Acronym / sponsor ID
- Rifaximin and Nutrition
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy, Portal Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Initiated study - PI left facility
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2014 (estimated)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether taking Rifaximin (Xifaxan) in conjunction with the use of nutritional concepts is effective in improving morbidity and quality of life in cirrhotic patients suffering from hepatic encephalopathy (HE).
Detailed description
Prevention of portal hypertension complications should be at the forefront. In doing so, the end result will be an improvement in the multitude of morbidity and mortality issues. The proposed prospective trial will compare patients with similar demographics and medical and clinical settings utilizing standard of care therapy. Study subjects will be randomly assigned into two treatment groups. Group one will receive Lactulose 30ml three times a day as SOC and Rifaximin Placebo 550mg twice a day with nutritional supervision and group two will receive Rifaximin 550mg twice per day as SOC and Lactulose placebo 30ml three times per day with nutritional supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose and Rifaximin Placebo | Active comparator | Drug: Lactulose, Drug: Rifaximin PlaceboStandard portal hypertension care, standard nutritional advice, Lactulose 30ml three times a day and Rifaximin (Xifaxan) Placebo twice a day. |
| Rifaximin and Lactulose Placebo | Active comparator | Drug: Rifaximin, Drug: Lactulose PlaceboRifaximin (Xifaxan) twice a day and Lactulose Placebo three times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female gender of Age 18 years or older
- Liver cirrhosis defined as one or more of the following: Radio-graphically proven portal hypertension (CT with nodular appearance) or Liver biopsy with cirrhosis
- Model for End Stage Liver Disease (MELD) score < 20
- Willingness to provide written informed consent, and participate in all study requirements
- Sodium greater than 130 meq/L
Key exclusion criteria (11 listed)
- Active alcohol consumption
- Serum total bilirubin level > 5 mg/dl
- History of hepatocellular carcinoma (HCC) and malignancies other than basal cell carcinoma of the skin
- Pregnant or breastfeeding women
- Subject has renal insufficiency requiring routine dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifaximinAlso: XifaxanRifaximin 550mg by mouth twice a day | Drug | Rifaximin and Lactulose Placebo |
| LactuloseAlso: Enulose, Generlac, Cholac, ConstuloseLactulose 30ml by mouth three times a day | Drug | Lactulose and Rifaximin Placebo |
| Lactulose PlaceboLactulose Placebo 30ml three times a day | Drug | Rifaximin and Lactulose Placebo |
| Rifaximin PlaceboAlso: Sugar PillRifaximin Placebo twice a day | Drug | Lactulose and Rifaximin Placebo |
Primary outcome
Outcomes of Change in Quality of Life Assessment Between the Two Groups
Time frame: Participants will be followed for 180 days
Quality of Life will be determined by the Chronic Liver Disease Foundation Questionnaire (CLDQ), the Sleep Scale by Hays, R.D.\&Stewart, A.L. and the Multidimensional Assessment of Fatigue (MAF) Scale and measured based upon Subjective Global Assessment (SGA).
Nutritional Improvement Between the Two Groups
Time frame: Participants will be followed for 180 days
These outcomes will be determined as Body Composition Analysis via the Quadscan 4000 BIA device manufactured by Bodystat;calories burned, steps taken and levels of physical activity to sleep efficiency will be measured via the Bodymedia CORE Fit actigraph device and various standard of care laboratories.
1 secondary outcome
Markers of improvement in general health
Time frame: Participants will be followed for 180 days
Results and safety
The study was stopped early (reason given: PI Initiated study - PI left facility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Neff, MD, MBA principal investigator
Tampa General Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin and Lactulose in people with Liver Cirrhosis and Hepatic Encephalopathy, run by Tampa General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI Initiated study - PI left facility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes of Change in Quality of Life Assessment Between the Two Groups (time frame: Participants will be followed for 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.