By: Carey Fried
August 8, 2017
CannaTech hosted a networking evening in Tel Aviv a few months ago. That’s where I met Vital, a 19 year-old, healthy, wholesome and strapping young man from the Netherlands. He was quick to smile, notably well mannered with broad shoulders and of average height (although, bear in mind that I’m looking through an American lens, and as Vital noted, he is a good a few centimeters shy of what the Dutch consider “normal height”).
He sat at a small cocktail table with his father Harm and I asked what brought them here to Israel. They were here to get a clinical trial off the ground, a trial using a medical cannabis protocol that they designed back in Holland to treat Vital’s Crohn’s disease.
What follows is their incredible story.
A Little Background About What Crohn’s Disease Is
Crohn’s disease is a chronic inflammatory bowel disease (IBD). It can affect any part of the GI tract, from the mouth to the stomach to the bowels and anus. It is most commonly found at the end of the small intestine (the ileum) where it joins the beginning of the large intestine (or colon).
Anyone who suffers from Crohn’s disease can tell you, it can be devastating. Symptoms include inflammation of the GI tract, pain, weight loss (often extreme), diarrhea, loss of appetite, low energy levels, multiple and unrelenting trips to the toilet. Crohn’s disease isn’t “just” uncomfortable…it can be life threatening.
At the age of 13, Vital, otherwise healthy and athletically inclined, started to experience some significant health issues. He struggled with low energy and recurrent diarrhea. He was unable to keep anything down and he lost his appetite. He lost weight… a lot of weight and the once vibrant young kid developed difficulty walking for more than a few minutes.
Towards the end of that year, Vital was diagnosed with Crohn’s disease.
He began treatment with Prednisone and azathioprine. It helped a bit, but not for long. Vital and his family had a name and an explanation for all the symptoms he was experiencing, but they hadn’t found a real way to treat it. He suffered for several more years before he discovered a better treatment.
Enter Google
Vital spent a lot of time on the internet. “I just started searching and cannabis came up again and again. I found a website called Chronology, (a patient powered research network and incredible resource) where people can rank their own home-found remedies. Cannabis is ranked the highest. Steroids are ranked 20-25.”
Vital continued to dig deep into the research about medical cannabis as a way to treat Crohn’s disease. His father, Harm was hesitant at first. He said, “I didn’t want him to become a stoner on top of everything else.” But after seeing how sick Vital was, he was willing to give cannabis a try.
Vital and his father turned to Israeli Professor Timna Naftali , who had published numerous medical research papers and had performed the world’s only clinical studies on cannabis and Inflammatory Bowel Disease.
Dr Naftali’s study tested patients who had smoked THC rich cannabis (approximately 200 mg). Vital and Harm decided to try as little THC as possible and explore delivery devices that didn’t involve smoking.
Because cannabis is legal in Holland, they were able to experiment with a range of products and devices. They tinkered with edibles and vaporizers and finally settled on cannabis extract oil that would be easy to dose. They used 12 mg of THC a day. “The oil dosing was something that was easy to maintain and easy to administer to and measure,” Vital said.
Sleep Through It
After one week of beginning their new cannabis protocol, in Vital’s words, something “magical” happened.
“You have to understand that I needed to use the toilet 12-13 times a day and about 3-4 times a night. It is such a difficult thing. So I never slept well, never slept through the night. But, I remember clearly, it was a Friday, a week after I started treating with cannabis, I woke up at 11:00 am.
You cannot really comprehend what that is like…it was really magical for me. The first time I slept through the night in years. That’s when I knew the cannabis was working.”
Three weeks later, Vital told his dad he wanted to play soccer again. “That was a great time,” he said reminiscing, “I just didn’t have the energy for that before.”
Fine Tuning the Protocol (aka Very Cool Science)
Crohn’s disease commonly affects the small intestine. The problem is, that ingesting an oil extract internally doesn’t guarantee that the medicine will reach the affected area the way it is intended to. The pH in our stomach is different than the pH of our small intestine and different still for our large intestine. So, administering this medicine in a way that would specifically target the inflamed area takes some engineering.
Harm’s background in is marketing, but he threw himself into this new research project and completely committed to engineering and developing a delivery system that would work as effectively as possible. He consulted with a local pharmacist and developed a pH sensitive, high CBD cannabis capsule.
The capsule is called an “enteric coated capsule,” meaning it’s coated with an acid resistant substance that doesn’t activate in the acidic environment of the stomach. Instead, the capsule passes through the stomach intact and only activates when it encounters an alkaline environment with a pH of 5.5 or higher, like, the small intestine.
Harm developed Vital’s dosing program: 25 mg of CBD internally and 12 mg of THC sublingually. That is the treatment protocol he has been on since.
*Editor’s note: Since the publication of this interview, the price of CBD has gone down in the Netherlands considerably; applying the “more is better” motto, Vital is currently taking 50 mg of CBD internally.
*Editor’s note: Since the publication of this interview, the price of CBD has gone down in the Netherlands considerably; applying the “more is better” motto, Vital is currently taking 50 mg of CBD internally.
Sharing the Healing
The treatment was so successful, they decided to study it further and see if this could work for a greater population. Vital and Harm launched a Facebook group called “Cannabis voor Crohn,” a closed group with around 650 members, in order to appeal to other Dutch patients that may be interested in starting a preclinical trial. They only needed 20 patients to get it started. But in a very short time, they had over 100 patients signed up ready to participate.
They were approached by the University of Groningen in the Netherlands to do preclinical research for the real trial they wanted to do. The University wanted data on 100 people to check dosing and response. Vital and Harm began supplying test kits that would provide all 100 patients with THC oil and CBD capsules for 10 days.
Vital explained, “because our trial was preclinical, we were not backed by any particular organization, so we had to pay for it all out of pocket. It’s expensive and not sustainable, so could only do it for 10 days. But that is one of the wonderful things about this… if the treatment is going to work, it will work in 10 days. If it doesn’t it probably won’t work for you.
How Did They Measure Progress?
Generally, in order to monitor progress one would check CRP in blood (C-reactive protein that is is an inflammation marker), and Calprotectin, (an inflammation marker in the stool). But because this project was privately funded, they didn’t have the option to draw blood samples so they did the next best progress indicator called the CDAI, or Crohn’s disease Activity Index, the de facto gold standard used in studies worldwide..
Simply put, the CDAI comes to a total score. If you lower your score with at least 75 points this is called “responding.” If you bring your score to below 150 this is called “remission.”
After 10 days of Harm’s medical cannabis protocol 70% of these 100 patients reacted very well lowering their CDAI scores by 75 points or more and some got below 150 points.”
Welcome results by anyone’s measure.
For the record, Vital’s CDAI is now 50 points. Earning him the coveted medical status: “in remission.” Moreover, after subsequent testing, protocol refinement (focus exclusively on patients with inflammation in the small intestine, not UC) they have discovered that 30 days is the optimal trial period to measure effectiveness, and their most recent response rates are between 80-90%.
Vital felt it was important to add, “people need to know that it’s not all roses. Our protocol is not a complete cure. I still have bad days. If I don’t eat well or find myself very stressed, I will pay the price. But this does treat the symptoms, it reduces inflammation and CRP markers. It gave me my life back.”