Dr. Parambir Singh Dulai, MD, associate professor of Medicine at Northwestern Memorial Hospital, the Director of GI Clinical Trials, and Director of Precision Medicine in the Division of Gastroenterology and Hepatology, talks about a unique treatment that reduces symptoms of ulcerative colitis.
Interview conducted by Ivanhoe Broadcast News in 2022.
What is ulcerative colitis?
DR DULAI: Ulcerative colitis is an autoimmune disease of the colon, so it can affect people as young as six months to as old as 80 years of age. It tends to occur more in people who are in their teens or early twenties and basically, they get debilitating diarrhea, bleeding, blood in their stool, need to use the restroom urgently. And the autoimmune component of it is basically your body’s immune system thinks the bacteria in your colon are bad and they keep trying to fight them off and the bystander in the whole process is your colon which suffers.
Is there something that sets it off or is it just anything?
DR DULAI: There are some known triggers, but for the most part, we don’t really know what causes it. And the entire component of ulcerative colitis is based on how we see its presentation as opposed to knowing what’s driving it. But one of the key drivers that keeps it going is a lack of oxygen in the colon.
How does colitis affect younger people?
DR DULAI: I mean, you’re talking about 16, 17-year-old kids who are trying to get ready for college, trying to go to prom. You’re talking about college students who are trying to figure out what they want to do with their life, people who are trying to get married, build a family. And on a daily basis, the only thing they can really think about is, I need to be near a bathroom. I need to be close to a bathroom. How am I going to get through the day? Should I avoid eating so that I don’t have to use the restroom? And it’s just a completely debilitating disease in terms of the burden it creates for them.
How is it traditionally treated?
DR DULAI: Traditionally, it’s treated with drugs that suppress your immune system. So, steroids, biologics, which are drugs that specifically suppress certain aspects of it. And they do a good job of treating the disease, but they have side effects. And I think one of the big things is that they’re lifelong treatments, but they only work long-term in about 30 to 40% of people.
What are the side effects?
DR DULAI: So, side effects can be getting infections. You can develop diabetes from and other complications from chronic steroid use. You can get skin cancers or blood cancers after long-term exposure. They’re effective therapies but the fact that they have some side effects and that they still only work in about 30 to 40% of people means we have a huge amount of room for improvement to figure out how to better treat these patients. Some people may get claustrophobia if they’re in there. They don’t like close spaces. So, if you’re not doing well with MRI’s, we can give you sedation. Very rarely, you can get ear pressure problems, just like when you’re going on a flight. But the technicians are amazing at helping you clear your ears, open those ear channels, and there’s probably about less than 0.1% chance that you’d have some trauma or damage that would occur. And with the number of sessions that we’re using for our studies, with only five sessions, there’s no risk of other complications really.
How did you come across hyperbaric oxygen therapy for a treatment?
DR DULAI: I was a resident at Dartmouth, and my research and career mentor at the time, Corey Siegel, started talking to me about new ideas, new approaches, and we started looking into the literature and we found some case series. So, some clinicians had used hyperbaric oxygen therapy for severe ulcerative colitis flares and saw some promise, some small studies where they had looked at a few patients and it began to make sense. A lot of the mechanistic or research or bench research had suggested that lack of oxygen was a big driver of disease and treating it with oxygen conceptually made sense. And there was some evidence that maybe it might work in some patients.
What makes sense about the hyperbaric oxygen therapy?
DR DULAI: Basically, the colon in ulcerative colitis, as we’ve seen, it has a lack of oxygen. Because the immune cells are coming in, they’re consuming oxygen, trying to fight off the bacteria. The bacteria are using the oxygen, and that low-oxygen environment then propagates the inflammation. So, hyperbaric oxygen therapy just drives a ton of oxygen into tissues by giving 100% oxygen and then putting pressure to push it into tissues that normally wouldn’t get it, like chronic wounds or chronic diabetic foot wounds. It’s the same concept. It’s just driving it into the colon instead of other tissues.
How often does someone have to do this and how long does the effect last?
DR DULAI: From what we studied, patients were coming into the chamber for 90 minutes, one session a day, for five days, and the immediate effect of the oxygen lasts for about an hour after they get out. But the effects the oxygen have on the immune system, the bacteria last for months afterwards.
Seems like a pretty inexpensive way as well to treat something.
DR DULAI: Yeah, I mean, it’s cheap, it’s easily accessible. These chambers are available in community hospitals, rural locations that don’t have access to world class experts or some of these expensive therapies. And it’s easy. I mean, I’ve gotten in the chamber myself. I got trained and certified in hyperbaric medicine so I could get a sense of what it was like. And you just sit in there, watch a movie for about two hours.
How quickly does it work?
DR DULAI: We saw people getting better within about three days. So, the studies that we did were hospitalized patients. Ulcerative colitis patients who needed to be hospitalized for a bad flare and had about a 90% chance of losing their colon during that hospitalization, we saw them getting better within about three days. And within about five days, their disease was completely back to a normal, healthy colon – healed, no bleeding, normal stool frequency. They were able to leave, go back to their lives and maintain that response for a few months.
So, why not just do this with everyone?
DR DULAI: That’s what we’re hoping to do. We’re in the process of designing and embarking on a phase three trial. We’re hoping to be able to get actual FDA approval for this once we get the results back, if everything looks promising, to make this widely available and approved so insurance companies will pay for it.
Is there a big cost with this from insurance?
DR DULAI: From the insurance side of things, there is. But when you think about it logistically, these patients are in the hospital. They’re already here for severe flares. The chambers are available in these facilities. So, I think we’re seeing a wider spread adoption already based on the prior studies that we’ve done. We’re hoping we’ll get wide adoption once we get our phase three study underway.
What are some positive side effects?
DR DULAI: The positives of it are so amazing. I mean, you’re talking about people who might need to lose their colon, and you’re preventing that and they’re immediately getting better, they’re feeling better, they just feel more energetic. They feel that sense of relief. I think it just gives them hope.
END OF INTERVIEW
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