NHS funded medical trials

Hiya, AyrshireK. Good to see you and a few of the rest of the gang are still helping us patients get a grip of this illness.

Thought i,d check you guys are ok and to let you know i haven,t got any worse as far as my own cirrhosis progression is concerned. I might begoing on a Rifaxamin medical trial through a Dr Vishal Patel NHS in London. You used to be staff didn't you? Do you think its worthwhile doing something like that if i,m accepted that is?

9 Replies

oldestnewest
  • Hello H1ghtower, yep still hanging around trying to help where I can. No, I never used to be staff - always just been a carer for hubby and done lots of research.

    What is the Rifaximin Trial, Rifaximin is already fairly routinely prescribed for Hepatic Encephalopathy and my hubby has been on it since June 2014. Don't know how his HE would have progressed without it but with it he still has sleepless nights, confusion, memory issues and some days like just now he seems to wandering around in a waking day dream like state. His doctors have said that he has HE symptoms.

    I think trials are a good thing, you get good care whilst on them and it's only through trialling do they find out if they work or not. Without trials, medical science would never progress.

    All the best going forward, Katie :)

  • Eyup, love. Thanks for the quick reply. The trial is on the following:

    patient.info/health/cirrhos...

    I must admit though after what you posted, my intentions aren,t really for the progression of medical science. They're for my own illness (cirrhosis)

  • Are you not already on Rifaximin H1ghtower? It's now pretty normal to get both Rifaximin and Lactulose to treat Hepatic Encephalopathy symptoms. I had a look at the trial details (to be honest I couldn't make head nor tails of it). I think (as you) that you just want the treatment necessary to look after your own condition.

    Katie

  • Think of the progression of medical science as a bonus. I'm not sure about this particular trial but my experience of medical trials is a win win. Better meds and Rolls Royce consultancy. Not to sound cynical but a lot of money gets spent on trials, and the best medics are involved.Make sure you understand the trial, fire away at questions and ensure it doesn't hamper any further treatment.

  • I've access to lactulose when needed but thats it as far as treatment for the cirrhosis is concerned. I dont have a specialist due to not turning up for my appointment with him so im reliant on my GP who comes to my house within 24 hours of ringing him so i can't complain. I dont think he,d heard of it though when i asked in the past , but, that could of been pre 2015. I,ll ask again on Monday now i know its available. Thanks for the heads up, sweetheart..

    Sup, RodeoJoe! Hows it going your end, mate. Not heard from ya for a while and thought you might you'd probably kicked the bucket!...only joking, mate. Glad you're still around, fella.

  • Yes I'm still about. Hopefully got years left in me.

    If I were you I'd try rebuilding bridges to get back to seeing a consultant. I don't think you can be guaranteed the right medical care through a GP. One thing I know about rifraximin is that it's very expensive, I also know that your local GP does not have the same budget at a consultant in a hospital. That could be why you're not already in this drug.

  • I am shocked your not on Rifaxamin wow it seems to be routinely given once H.E rears it's ugly head. As Ayrshire said I was on for 3 years and I not entirely sure what it did do or if it helped in anyway as I was still in and out constantly with severe H.E, got to point where consultant asked my husband to start dealing with it at home by pouring lactose down my neck and enemas galore. Do you have H.E mild or severe?

  • Hi, really interested in your post , I've been looking at clinical trials particularly in relation to hepatic encephalopathy (HE) could you give a bit more information as like others I though rifaximin was already tried and tested in the management of HE ...my husband has been taking rifaximin for last 5 years ...prior to that he was on neomycin. Lots of interesting information relating to management of HE through diet ....thanks and best wishes 😊

  • These are the details of the Rifaximin Trial that H1ghtower is referring to.

    Randomised Controlled Trial of Mechanistic Effects of Rifaximin in Cirrhosis and Chronic Hepatic Encephalopathy

    Brief

    Patients with cirrhosis are particularly prone to infection which is frequently a precipitant of hepatic encephalopathy, renal failure and circulatory collapse. Bacterial infections are of particular concern in patients with cirrhosis because they are poorly tolerated. Sepsis and associated endotoxaemia whereby bacteria produce inflammatory particles occur in approximately 40% of hospitalized patients with cirrhosis and is a major cause of death. Gut-derived and blood-borne pathogens can induce an inflammatory response within the liver and spleen, which are the major organs that remove bacteria and their endotoxin (such as lipopolysaccharide - LPS and bacterial DNA itself) from the bloodstream. Several mechanisms have been identified and proposed in this process which depends upon a balance between the barrier functions of the gut and the 'detoxifying' capacity of the liver. People with established liver cirrhosis have been shown to have escape of endotoxin into the bloodstream produced by bacteria that reside in their intestines, which becomes more permeable or 'leaky'. Gut dysfunction is defined by changes in the types of bacteria within the gut and in overall permeability allowing bacterial products which would otherwise be contained within the gut to travel into the bloodstream and lymphatic system with detrimental effects elsewhere in the body. This passage of bacterial products is termed bacterial translocation, and it's effects on the liver and general immune system can be then be measured. It has now become recognised that certain types of white blood cells such as neutrophils and monocytes become dysfunctional and this predisposes to infection and may also have a more direct pathogenic role in hepatic encephalopathy. Thus neutrophil and monocytes may be a novel pharmacotherapeutic target in a condition where current therapies such as bowel aperients (e.g. lactulose) are inadequate. A therapeutic strategy utilising Rifaximin, a non-absorbable antibiotic, to modulate gut bacterial which produce ammonia, a chemical known to be important in the cause of hepatic encephalopathy, could potentially lower gut-derived systemic inflammation, endotoxaemia, infection and organ dysfunction in this population improving outcomes and prolonging transplant-free survival. We therefore plan to test

    hide

    Conditions

    Brain Pathology

    Portosystemic Encephalopathy

    Fibrosis, Liver

    Hepatic Cirrhosis

    Liver Fibrosis

    Brain Diseases

    Fibrosis

    Hepatic Encephalopathy

    Liver Cirrhosis

    Other info

    Recruitment Status: Recruiting

    Enrollment: 50

    Gender: Both

    Age Range: 18 Years - 75 Years

    Study Phase: 4

    Study Type: Interventional

    Study Sponsor: King's College Hospital NHS Trust

    Study NCT: NCT02019784

    Last Updated on February 10, 2015

    Eligibility

    Inclusion Criteria:

    Inclusion Criteria:

    - Patients with established cirrhosis complicated by hepatic encephalopathy

    - For the purposes of this study a patient will be considered to have cirrhosis if they fulfil two out of the three diagnostic criteria of confirmatory liver histology, biochemistry and/or radiologic findings consistent with cirrhosis/portal hypertension, and

    - are presenting with chronic persistent overt hepatic encephalopathy (≥ grade 1) or with ≥2 episodes of overt hepatic encephalopathy in the previous 6 months.

    Exclusion Criteria:

    - Age ≤18 or ≥75.

    - Evidence of disseminated malignancy.

    - Known coeliac or inflammatory bowel disease.

    - Evidence of intestinal failure, intestinal obstruction and / or previous bowel resection.

    - Pre-existing immunosuppressive states including HIV infection and chronic granulomatous diseases.

    - Anti-inflammatory drug use e.g non-steroidals and immunomodulatory drug use e.g. prednisolone and azathioprine.

    - Known hypersensitivity to rifaximin or rifamycin-derivatives

    - Already receiving concomitant oral or parenteral antibiotic therapy e.g norfloxacin.

    - Infection with clostridium difficile or stool testing positive for clostridium difficile toxin in the previous 3 months.

    - Pregnancy or breast feeding women

You may also like...