Updates from Kansas City’s gastroenterology research center

Any patient with Crohn’s Disease will tell you they would love to hear there is a cure for the disease or at least a medical breakthrough that could cause remission or reduce their symptoms. Right now there is not a cure and we have to rely on medication and diet as well changes in life style and work schedules.  Everyone lives around their schedules, their children’s schedules, family functions, and other life events. Unless you have Crohn’s Disease. Then you live around your disease and everything is done if your digestive system will allow it.

Clinical Trials are for Guinea Pigs

Although I frequently see Dr. Taormina for my Crohn’s management, it never occurred to me to ask about clinical trials. Until recently, the thought of clinical trials brought to mind guinea pigs and horrible side effects. So when I received the call from Jody Ehrhardt about a study, I was skeptical. When and she said that the doctor thought that I would be a great candidate for the trial, I agreed. Dr. Taormina has been my gastroenterologist for two decades and I trust him.

No Relief for IBD

Digestive issues have been my major health problems for the past 22 years and for the first 10, I had been misdiagnosed by a general practitioner. After having a colon resection surgery and trying different medications, I had come to a standstill.  I had tried nearly every option for the IBD patient:

• anti-inflammatory drugs to treat inflammatory bowel disease
• immune system suppressors used to suppress the immune response
• Antibiotics necessary for injury due to IBD to reduce intestinal bacteria
• other medications over the counter and prescribed that help or used in conjunction with other medications
•  infusion treatments like Remicade and Humira

However for me and my Crohn’s, nothing worked.

Considering the Worms Clinical Trial

When the explanation of the Helminth OVA trail at the Midwest Center for Clinical Research was described to me, my face twisted into an awkward and painful look of disgust. If you think about it, swallowing a solution with worm eggs just sounds like some kind of test on a reality show. But, once I heard that in poor countries where water naturally has these ova that are consumed on a regular basis … and in these countries,  there are very few cases of Crohn’s Disease, Muscular Sclerosis, and Hay Fever to name a few … it made sense. And I decided it was something I should try.

I signed up for the clinical trial and after the initial testing, I was invited back for a very pleasant four-hour stay to drink the solution. I enjoyed my experience at the Midwest Center for Clinical Research. I took a nap in big comfortable reclining chair. There was a television and Wi-Fi available as well. Jody and Jennifer Payne at the research center were pining after me as if I was in a five star restaurant. Drinking the solution was easy; my wait to make sure there were not any negative effects of the solution was fun as I sat joking around with the girls. Before I left, Jody and Jen gave me contact information and my diary and the instructions were a piece of cake.

Improvements Through the Worm Egg Trial

During the two weeks after drinking the solution (which I do not know if I had the actual ova or the placebo) I did notice many positive changes in my symptoms. Regular medication was taken as usual, but the extra over the counter medication I would take was not necessary after a week into the study. The second phase of the trial where the solution would be consumed every two weeks was sounding better and better every day. Now, I am really hoping I can be a part of the next group.

Enjoying the Midwest Center for Clinical Research

The whole experience was very pleasant and welcoming. I felt comforted and reassured when Jody offer her personal number and said that I could call her at anytime. Where else would you have someone in a doctor’s office say, “Call me night or day if you have any concerns!” I’ve never looked forward to going into your doctor’s office until now.

The paperwork was beyond informative and the girls took all the time I needed to answer my questions. Even when there was a blood draw, it was painless and an easy experience. After going through the first phase of this trial, I found myself looking into the other trials and asking about participate in those as well. For anyone that has looked at the information posted in the doctor’s examinations room and wondered about these trials, ask your doctor. I’m definitely glad that mine called me.

Filed under: Crohn's Disease, The World of Research by midwestccr
No Comments »

Although I believe my crohn’s experiment was a step in the right direction for those of us who cannot truly understand the pain of the disease this description from our patient in response to my blog more accurately emphasizes our need for even greater understanding.

What many people fail to see and realize is that the trips to the bathroom are not the actual bad part. When you are experiencing an acid burn from frequent bowel movements that are soft or even pure liquid is a small part of this in a long line of embarrassing and depressing scenarios threw out an IBD patient’s day.

You experience pain when using the softest toilet paper or even the moist wipes that are now available. They are very helpful but they will still burn. On occasions, a SITZ Bath is necessary just to clean yourself and move on with whatever was interrupted earlier. There is an ointment called Nupercanial that is a God Send! This ointment has Dubicaine, which is not totally numbing the area, but definitely easing the pain from the acid burn.

Now if by chance you did not make it in time to the bathroom, you have to consider a shower and a change of clothing. It is not that a patient with IBD cannot wait; we cannot control the pure force of the urge. Imagine a shaken champagne bottle. The force of the pressure will build up only so much before the cork will blow and the liquid in the bottle begins to spray everywhere. This pressure and the loose bowel movements in combination will make an urgent and or messy situation.

If by chance, an IBD patient was cooking before this interruption. You will have soggy, burned, over boiled, etc… items you come back and deal with after you clean yourself up. Let us put ourselves in the grocery store. Through many cartons of melted ice cream, anyone can learn to choose all the non-perishable items first while shopping. Then make sure to know exactly where the bathrooms are located and if they are easily accessible.

One very important and surprising kicker with IBD is that you are never done when you think you are done. Most people who do not know about IBD do not realize that the IBD patient does not just have numerous runs to the bathroom. They also have frequent trips. You can be in that grocery store bathroom just finishing washing your hands and starting to walk out the women room door when, POW! You have to go again!

This is one of my embarrassing urgent trips while out at a public place.

My stepdaughter, son, and I had to go by Lowe’s to get something that my husband needed and as usual had forgotten himself. We are in this huge store looking for something when all of a sudden, I get this look, and my daughter says, “We will follow you and wait outside the restroom”. It is sad that my children know that when I have to go, everything else in the world must STOP so I can find the bathroom in time.

Imagine seeing a woman walking like a penguin quickly down the aisles and heading for the bathroom. As if no one will know, what my problem is at that moment. The closer I get to the bathrooms, which I would like to add are ALL THE WAY IN THE BACK OF THE STORE, my pace increases. I see the doors and run into the bathroom and into the first available stall. I breathe a sigh of relief that I made it and that I have not had another accident in public.

I sit and admire the pretty tile on the floor and the shoddy job putting it in, must have been one of their classes. A typical person is going to check to see if someone else is in the bathroom with me. This is where I will use some personal techniques to relieve myself and the other person in the stall next to me any embarrassment. Okay, mostly for me. There is the toilet paper muffler used to dull the sounds associated with expelling gas, there is the ever-important toilet seat gasket to keep me safe from previous messy users, and my personal favorite is the silencer. When you know you are going to have a bowel movement and you do not want to share the splashing noise associated with this or any type of void you can line the water with some paper to act as a catch net so you will not hear the sounds of nature at its finest. You can use these techniques alone or in combination. Never forget rule number one when it comes to bathroom etiquette, you can always offer a courtesy flush.

So I notice a set of feet next to me and I get into my rush strategy. I want to go and get it over with before the person next to me comes out and I have to face her when she just listened to me throw up from the wrong end. Well I push and force while using my techniques, wipe, get up and flush then wash my hands.

Phew! Another sigh deserved. I wash my hands and again I am thrown off by the pretty tile, I turn and grab some paper towels to dry my hands and leave. As I am throwing away my paper towels, the door opens. I look up and smile expecting to see my kids. NOPE! It is a man! He is standing there staring at me with this look of confusion and then looks at the sign on the door. He looks back at me, his eyes are telling me, “Um! You made a BIG mistake!” I shrug my shoulders, apologize, and walk out. Most of all NO, I am not embarrassed. I am happy I made it in time to the bathroom.

This was a single time trip, but imagine if I walked out of the men’s room and walked right back into the women’s room because the urge was there again. That too has happened and I will save that funny story for another blog. These situations go on forever and can put you in some serious physical pain while reading my moments of urgency. However, do you understand the frequency of the trip can also cause the drain of energy and depression? When your family comes to the bathroom to see you, you know you have an issue. Patient education, counseling, and support groups, there are not that many available. There is one in St. Louis and North Kansas City Hospital, which is at least 45 minutes to dive on a good day.

Basically, the point is that although your experiment was a really good try at understanding and IBD patients daily trials, no one can really know what we go through unless you go with us hand in hand and step by step seeing and doing everything we go through. The abdominal pain and cramping associated with the urgency to go. The nausea, flu like symptoms, depression, all the medications needed to try to reduce and ease the symptoms with IBD. The list goes on and on and the situations are sometimes beyond embarrassing. If I tried to sum up what an IBD patient goes threw in a day, we would need to write a book. Coming soon to your local bookstores. LOL There is nothing funnier than a joke.

~Toni Rinella, Guest blogger and Crohn’s sufferer

Filed under: The World of Research by jody
No Comments »

Quality of Life questionnaires are pretty standard fare in IBD clinical trails. The information gleaned from them is often used as a secondary endpoint in the trial. I spend all this time handing them and collecting the data without thinking about the actual meaning behind them.

So, what exactly is the definition of quality of life? It’s a pretty subjective endpoint don’t you think? As a clinical researcher I am looking for an improvement in scores after treatment. Decreased number in loose bowel movements per day, reduction in abdominal pain score, increased energy. The patient is most likely hoping for these items as well. However, and I am assuming a lot here since I do not suffered from IBD, I would bet that these items are just the measurable data researchers chose to define the desired outcome.

In order to better explain my thought process let me share a little experiment with you that I recently completed. After speaking with a patient who suffers from IBD and learning that she can have up to 20 bowel movements a day I decided to see what that many bathroom trips did to my daily routine. And, because these calls of nature probably do not present themselves at convenient times or on a preset schedule, I enlisted the help of my son.

So, here’s a little glimpse of my pretend day with IBD. Wake up, walk into kitchen for first cup of coffee, head to table to breathe in the energizing aroma and sip to my heart’s content. But wait- per my son who is my bathroom master it seems it time to make a dash to the toilet. I go, I sit, I think. Ok, so my morning cup of joe was interrupted and that’s annoying but so far not so bad.

Fast forward to 3 pm. I have made mad dashes to the bathroom 11 times so far. In the middle of doing dishes, at the grocery store with a cart full of product, on the drive home where finding a toilet took a bit of time, in the middle of making lunch, and even while trying to eat that lunch. Each time I sit, I don’t have to go but I am trying to stick as close to real life as possible. I make sure I am in the bathroom and away from the life going on around me for an adequate amount of time. I wipe even though I don’t need too. My bottom is getting sore. Honestly this sucks. I have left good conversations, had to eat cold vegetables, missed out on happenings that while not super important are part of the little things that make up life. Odd but I have to say I am starting feel left out and kind of alone.

By bedtime I am exhausted. Why? I wonder. It doesn’t take up much energy to sit in the bathroom. And the walk there isn’t really aerobic. Then it hits me. I am mentally tired. Tired of wondering when my son will announce it’s time to go. Tired of worrying about what I will miss or if my bathroom break will mess up the activity I am currently involved in. Bottom line- tired of worrying.

As I fall asleep I am thinking, “Can I really do this for another day?” By the time morning arrives I am pretty sure the answer to that question is going to be no. I was summons twice by my alarm to head to the bathroom during the night and woke up by yet another call of nature. This whole thing is really starting to make me cranky. Now my irritability is further pushing my friends and family away, resulting in even more loneliness and feelings of being left out. Before I can spend too much time feeling sorry for myself my loving son orders me back to what is beginning to feel like my prison- the bathroom.

Three days in and I have had enough. Yes, questions that measure the number of loose bowel movements in a day, severity of abdominal pain, and energy level are very crucial to assigning a degree to quality of life. However, for a true understanding of improvements I now believe that questions such as quality of relationships, levels of anxiety, and even feelings of insecurity should be included in these assessments.  Why? It’s surprising but even on day 4 when I wasn’t being summoned to the bathroom or wasting time on the throne away from everyone, I was still worried. After three days of living a life based on bathroom trips it had started to take over my life and the anxiety lingered.

Now take the results of my measly three days of experimenting and multiply that by months, years, or even a lifetime of dealing with IBD. Quality of life is in the tank! So yes, we need to treat the condition and improve the symptoms. However, in order to really help improve our patient’s quality of life, I think we need to offer more.  We need to other services or at least provide resources to these services since there is obviously so much more to dealing with this disease then just the medical symptoms.  Counseling, coping mechanisms, family education, and even work place education for co-workers and supervisors need to be a standard part of any treatment plan for IBD.

Filed under: The World of Research by jody
No Comments »

The old adage “The customer is always right” gets thrown around a lot in business but how often does anyone give real credit to the phrase? Well, today made me think about that saying in a whole new light.  Maybe it’s not just about who is right when a customer is angry, but rather it’s a reminder that what your customer thinks is important and that listening to them is right.

Working at a clinical research site focused on gastroenterology issues should cause me to be more aware of certain bathroom issues. However, the fact that I do not personally suffer form Crohn’s Disease, Ulcerative Colitis, or any other GI issues leads me to take things in the bathroom for granted. Let’s face it- how often do you really think about your bowel habits, the proximity of a bathroom, or the toilet in a public restroom? I never do. The closest I might come to actually putting thought into my bathroom dash is when my bladder is about to burst. Once seated my thoughts always drift (drift because everyone knows that the longer you “hold it” the longer you spend in the act of peeing!) to the real pros of depend undergarments- no more having to leave the long lines at World’s of Fun right before its your turn to ride, no more wasted time on long road trips! If I had my way everyone would be wearing them!

But honestly- I do not think about bathrooms. But a research patient spending four hours at our facility for a clinical trial definitely does.

Sometime after hour two, and quite a few bathroom trips in, our super sweet, super funny study patient exclaims, “Have you ever considered getting softer toilet paper for your bathroom? I mean, it’s fine for once or twice but GI patients could really use something more geared toward their use and their condition.”

My first thought? I wanted to smack my forehead like they do on cartoons and shriek DUH! How had we not considered that? We treat patients with severe diarrhea, constipation, hemorrhoids, etc. and yet we missed the opportunity to be very selective with our toilet paper???? It seemed so obvious yet it took a patient to point it out.

My second thought? Thank gosh for patients, especially those that feel comfortable enough with their providers (or in this case research coordinators) to bring up concerns, comments, or requests.  And, the fact that our patients do feel comfortable enough to request softer toilet paper from our office? Well that’s a testament to the fact that even if we picked bad on toilet paper we did do something right!

We care enough to make our patients comfortable whether they are sharing concerns about their illness or our choice in paper products.  And now, thanks to a certain research patient, we also care enough to stock the bathroom with soft, absorbent tissue!

Filed under: The World of Research by jody
No Comments »

Clinical research trials are serious business. Any time you are dealing with patients’ health, investigating new treatments, weighing the benefit/risk ratio of trial entry, and creating and collecting data that can change medicine you need to approach your day with concentration and gravity.
That said- there isn’t any reason why relationships can’t be built and a bit of fun had by all parties involved in research. With the holiday season behind us our staff had stopped thinking about pretty packages and turned our thoughts to patent visits and data and lab collection. However, one of our clinical trial participants had other things in mind. When asked to return an early morning stool sample collection she threw out the boring white bag supplied to her for sample return and instead decided to “dress up” her sample with a bit of mischievousness and cheer. Her stool sample nested inside red tissue paper in a vivid santa bag brought smiles to our faces. More importantly though, her small gesture served as a reminder of why we really do this.

Clinical research is about helping patients find relief. It’s about increasing quality of life. It’s about those six little words we long to here, “I’m feeling so much better now!” It’s about all of us working together to improve medicine. And… it’s about happiness disguised as lab samples in Santa bags.

Filed under: The World of Research by jody
No Comments »

Three days in Florida resulted in more than just a rosy glow to my cheeks (which was actually due more to a robust, nonstop wind than any hint of sun). Conference information, updates on future research projects, and numerous meetings with the powers that be at pharmaceutical companies resulted in more treatment choices for our patients and community.
So what’s new and upcoming at the Midwest Center for Clinical Research?
Crohn’s suffers can explore new treatment options offered by Bristol Myers Squibb, Glasko Smith Kline, and others. We have oral doing trials, infusion doing trials, and even an exciting phase 1 trial we have high hopes for!
Patients with Ulcerative Colitis can explore new treatments offered by Bristol Myers Squibb and Santuras. And for our patients suffering from IBS we have new options too.
If you are interested in participating or would just like to know more about research reach out to us at info@midwestccr.com or post your thoughts to this blog!

Filed under: Uncategorized by jody
No Comments »

The Midwest Center for Clinical Research in Lee’s Summit, MO is the first site out of 350 global sites to successfully recruit participants for two new Johnson and Johnson drug trials. The research center has also successfully recruited the first participant for a Bristol-Myers Squibb study, an industry honor titled “First Patient, First Visit.”

“Dr. Taormina and Jody Ehrhardt have successfully opened a clinical research site and far exceeded
Johnson & Johnson’s expectations,” said Kristina Galante, Global Trial Manager for Johnson and Johnson
Centocor. “The dedication shown by their research team has proven to be successful. In addition they
have met all FDA requirements and have been adequately trained to participate in new trials, which is a
crucial step to allowing patients access to cutting edge treatments.”

The Midwest Center for Clinical Research was created as a division of Midwest Gastroenterology
one year ago. Together the research center and gastroenterology practice find solutions for patients
suffering from Crohn’s Disease, ulcerative colitis and other Irritable Bowel Disorders (IBD). The research
center has already recruited over 60 participants who volunteer for investigational drugs with hopes of
finding relief for the diseases they fight.

“Our goal at Midwest Gastroenterology and the Midwest Center for Clinical Research is to serve our
patients who suffer from Irritable Bowel Disorders. As experts in IBD, we have a dedicated infusion
area and nurse who specialize in treating patients with these disorders, and we offer traditional
and investigational drugs to help our patients find relief,” said Dr. Marc Taormina of Midwest
Gastroenterology.
Putting Kansas City on the Map for Clinical Research

Clinical research trials allow participants to play an active role in their own health care. Research trials
allow access to new treatments before they are widely available to the public, and offer solutions to
those who have no relief from current medications. Typically, drug companies will look to more highly
populated areas first when introducing a new drug trial; however, the success of Midwest Center for
Clinical Research has highlighted Kansas City as a successful area for clinical research.

“Recently a clinical research associate informed me that our success has proven that people in the
Midwest have positive feelings toward clinical research, and that it is a growing area for research,” said
Jody Ehrhardt, Director of the Midwest Center for Clinical Research. “Drug companies usually looked
first to the highly populated east and west coasts for new trials and didn’t put Kansas City, MO towards
the top of the list – but they do now.”

Midwest Gastroenterology is a leading expert on IBD disorders in the Kansas City area, specializing
in treating patients with Crohn’s Disease, ulcerative colitis, among others. Drs. Marc Taormina and
Wade McCullough have helped sufferers from IBD disorders find relief through treatments and surgical
procedures in the Lee’s Summit facility.
About Midwest Center for Clinical Research

The Midwest Center for Clinical Research was founded in 2010 to offer investigational research trials to
gastrointestinal disorder suffers. The clinical research center operates several drug trials through global
drug companies such as Johnson & Johnson, Abbott, and Bristol-Myers Squibb. Located in Lee’s Summit,
MO, the research center meets all FDA requirements and has a dedicated team of professionals who
provide guidance and support to participants of each trial. For more information about Midwest Center
for Clinical Research, visit www.midwestccr.com or call 816-251-1258.

Filed under: First Patient, First Visit by midwestccr
No Comments »

(dated 8-24-10)

Midwest Gastroenterology Partners is proud to announce the grand opening of the Midwest Center for Clinical Research, a research center housed in the Lee’s Summit facility for all patients to participate in clinical research trials.

“Participating in a clinical trial can be a rewarding and beneficial experience. Some of our patients will participate so they can help others diagnosed with the same disease while others will volunteer in an effort to help find new treatments or cures for a disease they have yet to find relief from,” said Jody Ehrhardt CCRC, Clinical Research Director for Midwest Center for Clinical Research.

The facility performs clinical research trials encompassing drug testing, phases 2, 3 and 4 clinical studies, endoscopic research and outcomes research. Midwest Center for Clinical Research is currently performing studies for Crohn’s Disease and Ulcerative Proctitis, and will be beginning studies for constipation, and diarrhea predominant IBS in the fall.

“Our research division not only opens up the opportunity for our patients to try the latest medicines, but to help others in the future diagnosed with their same disease,” said Marc Taormina, M.D.

Filed under: First Visit, Research Press Releases by midwestccr
No Comments »