Vancomycin Trial

This is opening up again. I do believe when I attempted to get in a couple years ago your ALP had to be 1x5 above the normal:

At the time I qualified, happy to say I don’t right now - however I take an antibiotic daily for my autoimmune Rosacea so I was disqualified.

I think it is very exciting they are still taking participants. The one time I went on High Dose of Vanco was after a bad cat bite. Just happened ot have my labs done right before and a few weeks after. My ALP definitely dropped - so I’m encouraged to know that perhaps one day when push comes to shove Vanco might be a good fit for me - even though I am 56. Most say it works best in younger folks.

Here’s the info copied from an email:

logo

Dear JENNIFER ST LORANT,

A feature of the PSC Partners Patient Registry is to provide researchers a way to communicate clinical trial opportunities to Registry participants.

Mayo Clinic has sought the Registry’s help in locating PSC patients interested in their vancomycin trial, Treating Adult Patients with Primary Sclerosing Cholangitis with Oral Vancomycin in a Randomized Trial .

Please find below Mayo Clinic’s message about the trial, followed by a Q&A conversation between the Registry Director Rachel Gomel and a Mayo study researcher.

Message from Mayo Clinic

Primary Sclerosing Cholangitis (PSC) Research Study
Mayo Clinic researchers are looking for people with Primary Sclerosing Cholangitis (PSC) to participate in a research study. The overall goal of this study is to examine the safety and effectiveness of daily dosing with oral vancomycin versus placebo.

What is PSC? PSC is a disease of the liver characterized by ongoing inflammation of the bile ducts, which can ultimately lead to cirrhosis and end-stage liver disease (ESLD).

What happens during the study? For each study participant, the study participation period will consist of 5 visits which include: the screening period of up to 1 month, treatment period for 18 months, and a follow-up period of up to 6 months. Participants will be randomized to either the placebo group or the active treatment group.

Who can participate? To participate in this study, you must:

  • Be between 18 and 75 years old
  • Have a diagnosis of PSC consistent with the guidelines published by the American Association for the Study of Liver Diseases (AASLD)
  • Have had an ultrasound that excludes biliary obstruction and malignancy within 6 months of study entry

For more information :
Arizona: Saran Vaughn at 480-342-6487 or Vaughn.Saran@mayo.edu
Rochester: Mitchell Clayton at 507-284-2698 or Clayton.Mitchell@mayo.edu
Florida: Robert Brannock at 904-953-3238 or Brannock.Robert@mayo.edu

Dated: August 16, 2021

I got this yesterday too and talked to one of the people at the Mayo Clinic running the study.

It’s not convenient for me geographically, but I’ll make it work if selected. They said it’s a liquid form of vanco taken 4x per day. Is it normally a liquid or is it in pill form usually?

Eric

What’s the basic criteria?
ALP has to be?

Geographically because you have to travel? Or Fly?

I only belong to this group now. But prior I followed 3 FB groups too.
Vanco seemed best for many by
Manufacturer
Pill Form
Chewing Pill prior to swallow. More common with folks over 40ish

I read much more on it being beneficial to the younger. A few over 50 had results for a while- but PSC marched over its benefits. I think it’s sad they didn’t at least test test the theory before he was so sick. It’s expensive and insurance, most lare similar to my private insurer, say haha fat chance we pay
My cat bite 6 pills Vanco? 650. With insurance over 800
It’s an excellent antibiotic and I can appreciate why they are so careful.

Bottom line on this post- If you can get in a trial like this , it’s continuing for a reason. I believe when I applied it was a pill form, liquid was never mentioned
I wish I could remember the dosage

Did you ask dosage?

I’ve another study in diet I tried in November 2020 to get into. That’s when my ALP dropped. Happily I think still down. But now they are requesting fecal samples of PSCers
You just fedEx it back lol
I did not get a definitive answer on if I would get results specific to me
That’s the cool part of studies…. Data specific to you are another’s cost ; )
I’ll post it if they are looking.

My hepatologist had a study delayed by Covid and I delayed as it required at minimum 2 liver biopsies. When I committed in April 2021, fully vaccinated, the day I was to start the process over - they quit taking participants :roll_eyes::slightly_frowning_face:

I ramble :blush: but studies are fascinating. I’ve done a lot of preliminary but never got on board

Good luck figuring it all out!
Go for it if you can.
Jenniferc

The only criteria are labs/mri within 6 months. No obstruction or cancer and can’t be taking any other antibiotic.

Yes, due to travel. You have to go to minn, az, or FL every 6 months.

Study is 18 months, double blind. She didn’t mention dosage but made sure I was ok with frequency, which of course I am.

I tried to get into a different trial in July 2020 but was turned down to to my BR level(it was a 7) and my doc didn’t do anything til it got to a 14, and that was me insisting on it.

I’ve switched doctors now and the new one seems much better. She told me to check with The Cleveland Clinic but I can’t get anyone in their GI dept to respond to me.

I’ll update here in about a month to let you know if I got in this one. My testing is week of 9/13 and the results are being sent to the Mayo Clinic who run the study.

Eric

Hi MzzP, that’s great that your rosacea antibiotic lowered your ALPs! I’m curious which antibiotic it is and how much it lowered your numbers. Thanks!

Hey Joki
I wasn’t super clear
The antibiotic does nothing for PSC
It just got me disqualified from a vancomycin trial

It does work well for my Rosacea however.

Sorry to hear that you didn’t get in to the trial! You should however be able to get it if you want to try it. A bunch of us on this forum have been taking vanco for years, with very good success. :slight_smile:

It’s expensive but not unmanageable if you take the liquid form. It costs about $220/month without insurance if you take 500mg/day (as long as you use the coupon from GoodRx).

Hi Andreas,
Good to hear that others here that are over 50 are having good luck - that’s the group that seems to not have as good of results.
Keep up the awesome Labs and Health! : ) : )
Jennifer

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Some more data on Study:
Study requires 5 visits on site if you qaulify
ALP must be 193 or higher per Mayo lab range
You start out at 2.5ml, 4x per day liquid Vanco and after 6 months if your ALP has not dropped you get bumped to 5ml, 4x per day.
At 12 months if you ALP remains high they bump you up to 7ml, 4x per day. That’s the max.

It is a 2 year trial with 18 months of actual Vanco or Placebo.

I forgot to ask if you are eligible to receive your personal health data generated during this study. I would assume so and 1/2 the reason to do it. Love me some free medical data specific to PSC!
Sadly, she did clarify that the fact that the antibiotic drug I take for my Rosacea, automatically disqualifies me. She even went on to say that if the FDA did approve Vanco for PSC that there may be a possibility I would be denied due to taking the antibiotic Oracea. Just an FYI - some drugs you need might make you ineligible for a potential life saving drug when no other doc has ever hesitated to give you or me vanco for other issues unrelated to PSC lol

It’s a quick phone call. The AZ contact picked up on second ring : )

Hi Jennifer! I believe that it has more to do with disease progression and not necessary age. Most people who are 50+ have a much more progressed disease than kids (since it takes many years for PSC to progress). Vanco seems to work for people with early stage PSC, and less well for those in late stages. :slight_smile:

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Andreas,
That makes good sense and I agree. It is why, however, I still am frustrated that older folks with early stage are not able to get it/at least try it should things start to go south. I know my hep who is very open minded wasn’t quick to say, yes we will try it if your ALP jumps again. She brought up the “age” factor. She brought up the age factor during our first meeting when she explained to me what PSC is and what it means.

Happily my ND PC doc is like, if she doesn’t prescribe, I will. She’s like a ND with MD and Pitbull thrown in lol

Now everyone just cannot retire before I might need them : ) I just found a gastro guy I love too. It’s damn hard to find docs that are knowledgeable about PSC (or at least willing to study) and then be open minded to alternatives or at the very least what is working for me.

You take good care - thank you so much for the conversation!
Jennifer