I am going to paste the email I received from pscpartners.org - as it best explains the importance and urgency. I just received this email, so timing is of the essence if interested. Go to the Show More below video and you will find a link to more information about the study.
Please reach out - the more of us that do, the more apt researchers will be open to studying our rare, incurable, expensive and deadly disease. They have worked very hard to create a study that is as Covid-19 friendly as possible. I’d hate to lose their confidence in US to do our part to Fight Back against PSC and promote others to Want to Fight For and With Us.
We NEED to show that when researchers come to PSCers, we respond. Can we demonstrate, before the big Oct meeting, that PSC patients will engage with research?
A study adapted to minimize risks of COVID-19 is recruiting now.
- CONDUCTED REMOTELY AT YOUR HOME
- NO DOCTOR’S OFFICE OR HOSPITAL VISITS
- CONSENT OVER THE INTERNET (eConsent)
- DIETARY COUNSELING BY VIDEO WITH A DIETICIAN
- A $600 STIPEND FOR FOOD AND HOME DELIVERY
- OPEN TO PSCers RESIDING ANYWHERE IN THE U.S.
This is the first nutrition study ever conducted on PSCers. And this is the first time that researchers have responded so fully to patient input on study design. We’ve been asking for guidance on nutrition and we’re excited that researchers are responding!
Here is our perfect opportunity to show the FDA on October 23rd how engaged PSCers are! Respond to the efforts of these researchers who went through gigantic efforts to develop a COVID-safe, patient-friendly study! Take this opportunity to show the FDA, the decision makers, that we want research and clinical trials! Even if you eventually do not participate in this study, contacting the Harvard research team today to find out more to help inform your decision will be helpful and will demonstrate engagement.
The study model itself is of importance (remote; no placebo). We want to be able to show that this model can work. We don’t want companies to be discouraged from studies in PSC, and we want to move forward with additional studies. It would be so powerful if the registry team could make the following announcement to drug developers and researchers at the upcoming Making Our Voices Heard: Patient-Focused Drug Development Forum with FDA on Oct 23: " A call for participation was sent out, and in two weeks enough patients responded to fill the study ." This would send a powerful message that investing time and money in this rare disease is worthwhile.
Contact the researchers to find out more about this study today!
Email PSCresearch@bwh.harvard.edu or call (617) 732-9481
Thanks for sharing this! I just emailed them.
My first reaction upon reading this announcement is that they need at least 250 participants to start a study. PSC’ers are few in number, so please sign up and do some good for our community. We all have so many unanswered questions about PSC, and so do our doctors. We are living experiments and the more we can share from our experience, the greater the information database becomes.
Did you ever hear back? I have not heard back on my phone call. Part of my frustration with studies is the lack of follow through on their end. It’s a lot of work to get into a study and most do make it easy or come across as super willing to let you know how much they appreciate your efforts to at the very least contact them.
Love to hear if you had any luck!
And Thank you!
I think this is just a small trial to see how it goes under a more open and less controlled format. If they saw positive results, I think they would broaden and and add in a placebo. But as you know, when the diseased, nobody wants to be the placebo… even if they didn’t participate they actually are being one!
Thank you for your wise input. And always a pleasure to hear from you. I hope this finds you continuing to do well!
They emailed me back last Friday and said they were going to start calling potential participants this week for more information. So I would try emailing them.
The link for study details seems broken.
So frustrating - it was working fine prior.
I googled the study and came up with this.
I just updated my original post. Thank you! Hope the youtube link works and then the link underneath it.
I had a superb conversation yesterday - I hope you too have made contact. Not sure I’m eligible due to my ALP not being higher, but I sure liked the sounds of their thinking. Let us know if you hear and how it goes! I understand they did have up to 100 folks respond - very exciting.
I finally heard back yesterday. Did you touch bases with them? Any word back? My conversation was excellent and really got me thinking about diet and gut health even if I’m not eligible.
Keep us posted!
I forwarded the info to my son. I am not sure if he followed up on it. Just wondering what kinds of foods they are leaning for in the study. Is it exclusively vegetarian or combination, low carbs and/or high protein etc?
Good to hear that they are contacting even though someone is not eligible.
They don’t know if a person is qualified until a conversation is had and they complete the next phase of getting access to most recent medical records from one’s hepatologist / GI / or whomever is handling one’s PSC.
One diet is more vegan with plant proteins, the other is lower carb - from my conversation yesterday. Folks are chosen at random by a computer and from here you work 1-1 with a nutritionist. It’s quite a process to get started, but not anything more or less than other studies, based on my personal experience.
Bottom line they have discovered that Sulfur is a player in IBD and PSC acting up. Sulfur is produced naturally and is a bi product of gut bacteria breaking down of proteins. All types of protein breakdown create sulfur, but from the tiny bit I garnered, with animal proteins it’s more or different, for lack of a better explanation at this juncture. She assured me there would be plenty of protein in the more vegan. I eat animal protein at least 5 or more times a week. I tried vegetarian years back for 11 years and didn’t find I felt that great. However, if I should be eligible in this study, I’m totally excited to try something new - what’s 8 weeks? And, if they find positive conclusive evidence, then they will do a larger, longer study. Bottom line, we know gut bacteria are a HUGE player in PSC and any type of IBD, IBS, UC or Chrons. We know diet matters when dealing with flare ups of all.
Best of luck to your son - an email of phone call at the very least gets him into their database. That is the Up Side to researching and acting on it, there is piece of mind knowing I’m in Mayo’s database and my local hepatologists database for future studies. We just never know.
Thanks Jennifer for a quick summary on their diet plan. Sulfur playing a role is interesting. Wow, participants get to work 1-1 with a nutritionist . That’s a well thought out plan.
You are most welcome
One item I neglected to mention was that excess sulfur results in inflammation and this is the crux of PSC and IBD - that darn inflammation.
Here is a great article on Sulfur in our diet by my favorite site ncbi