This guest post was written by a parent who diligently seeks and studies the most recent IBD research. She is a mom of an amazing daughter with Crohn’s and Celiac. She holds advanced academic degrees and has professional background working in science-based corporations, and she generously shares her knowledge and observations with our parents community.
In order to gain a wider perspective, we have included the summaries she shared in the past three consecutive years. You will notice that the focus on medical diets is changing and evolving from year to year.
Notes from the IBD Education Day at Children’s Hospital Of Philadelphia, February 2020
The morning began with an IBD 101 intro, a review of current medical therapies and a look forward to future therapies. Imaging was also discussed. Several CHOP GIs and the radiologist then answered some previously submitted questions and this was followed by a patient panel (the cutest part of the day!). The final portion was a “breakout” to either a nutrition session, an integrative health session or a patient family support group. The diet session was by far the largest and that is the one I attended.
It was good to see promotion of EEN as one of the existing therapies and their protocol is to do 80%-100% for 7-12 weeks for induction of remission and then 5 days/wk formula for maintenance titrating down to whatever level will maintain the remission. No discussion of transition to any diet. I am not really aware of evidence to support this latter maintenance plan as studies of PEN are not fantastic, but it’s interesting and I would be curious to know their success rate in practice. The formulas they specifically mentioned were Kate Farms, Peptamed Jr, Pediasure Peptide, Boost and Ensure. They said symptoms should be better by 2 wks, remission by 7-12 wks. EEN is only recommended for Crohn’s not UC but they did also say that diet therapies are an “important part of every child’s care plan”.
Regarding existing medical therapies, the consistent theme of the last few years is to medically treat early and aggressively, usually with Remicade. Humira, Entyvio and Stelara are also used. Older treatments like 5 ASA and immunomodulators have a role, but are used much more sparingly in the biologic era. Steroids (including older corticosteroids and newer budesonide formulations) also have a role but they try to avoid them due to risks / AEs and lack of mucosal healing.
I asked a question about whether they do therapeutic drug monitoring (TDM) proactively or reactively for these drugs, and the response was that they test drug levels and antibodies after the induction period for Remicade and Humira and that they have a study ongoing for TDM of Entyvio called VEDOKIDS.
I also asked whether they are doing clinical testing for the new biomarkers that can show whether someone is very likely to fail Remicade or Humira (HLA-DQA1*05 allele, Oncostatin M and TREM1) but unfortunately they did not answer this question. I think the answer is likely NO and I would personally like to see patients asking their GIs about these non-invasive tests that are evidence-based!
Regarding future therapies, they noted > 100 actively recruiting Phase I – III trials in the U.S. They discussed one drug for fistulas called darvadatrocel which has shown approx. 52% remission at 6 mos/ 1 yr vs 36% in placebo. And they discussed the potential for stem cell transplants, which truly is only relevant in the sickest patients as it is a very risky process. I was a little disappointed this was the focus of that presentation. A deeper dive into the various new mechanisms of action being studied would have been welcome.
They also generally discussed personalized medicine, including microbiome studies and genetics, but the reality is that none of this is being done in practice, except in some Very Early Onset (VEO) patients. As the GIs say: “it’s not ready for prime time”. We have been hearing this for years so, again, it would be great for patients and parents to advocate for a move to utilize the personalized medicine tools that do exist. The RISK study is one, new predictive commercial tests are coming to market, and we have the biomarkers I noted above.
Regarding IBD imaging, the radiologist primarily discussed scopes and MREs and what resources are in place to help young patients deal with these procedures (which is great!). We were told that even perfectly healthy IBD patients should get scopes at least every 3-5 years. They also had a slide mentioning Ultrasound “with or without contrast”, although this was not discussed. The presenter said they would work with families who do not want contrast for any procedure, although image quality may suffer. I found this reassuring. When specifically asked about contrast safety, she stated that they are “quite safe” but could spend a day talking about that question, so it led me to wander what she wasn’t saying? She did say she hasn’t seen it making Crohn’s worse but that it can cause nausea, vomiting or allergic reactions. Obviously, imaging is important but there are questions that should be answered, especially about using US and pill cams more regularly.
During the Q&A, a question was asked about the definitions of “remission” and when we should expect to see it. Multiple GIs explained symptomatic vs serologic vs endoscopic vs histologic remission and said that one should see some response to a medication in 12- 14 weeks but they look for remission at 6- 12 months! Keep this in mind when someone tells you that diet has failed because your child is not in remission after a month! It’s always a balance because, depending on disease phenotype, severity and patient preference, medications may well be needed asap, but it’s always worth asking questions of your team about the double-standard between diet and meds.
Fecal calprotectin was consistently raised as an important and reliable test, but it does not replace scopes/MREs. One GI stated that it is “individualized to a person and a lot of factors can impact it”, which was somewhat surprising to me. I am not sure what that statement was based on (other than I am aware of studies showing time of day can matter, lab can matter and obviously infections can affect results).
Someone raised a question about the possible role of MAP and Dr Kelsen, one of the many GIs I greatly respect, said that MAP and a number of other bugs “have been identified”. She said “MAP is just one” bug and to only test for it if the evidence is overwhelming (although I cannot imagine what that would be without testing). She correctly stated it is very hard to test for (as there is currently no validated tests available, though some studies are ongoing, including at CHOP). I found all of this interesting because my own hypothesis is that many IBDs may be triggered and/or exacerbated by untreated infections. But again, we need to push for testing of a wider range of potential infections (ie beyond c diff, sometimes a handful or viral infections and a routine ova & parasite test).
Fecal transplant was raised again this year and got the response “not ready for prime time”. Dr Kelsen said it is “absolutely not clear” but that research is ongoing.
Medical marijuana was also asked about and, and like in previous years, there was a firm NO. Dr Kelsen stated that “evidence is not supportive as a medical therapy”.
For our college age families, a good question was asked about whether to switch from Remicade to Humira to make college easier. The GIs said probably NO because “the first med has the highest success” rate and switching is a risk. This point is very important and supported by research: whatever treatment you choose first has the highest chance of success. So consider diet as an early intervention to maximize chances of success.
A question was asked about whether they think any group of kids is more likely to develop antibodies to Remicade or Humira. Interestingly, Dr Conrad said “younger kids”.
There was a patient panel again this year. As in years past the kids are all absolutely adorable and brave and amazing. But my heart breaks for the ones who were clearly struggling physically or emotionally, changing meds or one college student who had a recent colectomy after 4 years of struggle. I could see her trying to be positive but choking back emotions as she said “colectomy”. One adorable boy was doing SCD + Remicade and I absolutely loved that he thanked his mom for doing lots of cooking. Amazing dedication!
Finally, in the diet breakout session, they basically just put a Mediterranean Diet slide (although not a single study has been done on that diet in IBD, one is ongoing). I agree this has a great deal of evidence as a healthy eating pattern for everyone, and may even be preventative. I just question its use to treat IBD. I think the research suggests we can do better and give more targeted advice to IBD patients.
(Another parent reports from the event: My husband sat in on the Nutrition session, so that I could meet Dr. Albenberg at the Integrative Health session. At this session Dr. A mentioned that SCD is a 50y/o diet, and they aren’t sure why it works for some. She then went on to talk about the Mediterranean diet as showing promise. It was mentioned that there is a study beginning which compares SCD to Mediterranean, in adults, info can be found here: http://dinecd.web.unc.edu/)
Also discussed was an interesting diet study they conducted to see how the diets of kids with IBD differ from non-IBD kids. They actually found that BOTH groups ate a Standard American diet (ie SAD), but that kids with IBD ate even fewer fruits and vegetables than non-IBD kids! Exactly, the opposite of what we should be advocating (absent strictures) for IBD Kids. It was terrific to hear the that fiber is helpful not harmful and I applaud them for that. But I do feel research supports fiber from fruits and vegetables over grains and that was still not the message we heard. We are making progress, even if it is slow!
Here is my takeaways from the day:
General observation – Overall, I am always grateful that these busy GIs have taken the time to present to families. That said, as a caregiver and a parent, and as someone who follows the research closely, it is difficult to see the sometimes needlessly slow pace of progress in the clinic. Some of the slides were recycled and the studies referenced were in many cases over a decade old. I would have liked to see a presentation of newer and more current studies and data and a deeper dive into the many significant issues that we know GIs debate with each other. Caregivers and patients, especially those attending these IBD Days, are engaged, sophisticated and educated and anyone having these sessions would be well served to know their audience.
Notes from 2019 CHOP IBD Day
My overall impression is that we have come a long way. Diet was a central theme this year and every speaker addressed it. It is now clearly an important component of their treatment of IBD. I am told it was also the most popular of the 3 breakout sessions.
Here are all my notes and take-aways:
The message was that we have many more treatment options than we used to have and are also much better at optimizing treatment. Biologics are generally safer than thiopurines and steroids, although thiopurines are also generally safe and well-tolerated. Methotrexate and antibiotics are used as well. New biologics addressing different inflammatory pathways (like Entyvio and Stelara) are and will continue to be approved. They are also starting to use Xeljanz in kids. Apparently, some adult GIs now use Stelara as first-line therapy because of the safety profile.
There are currently 71 US Clinical Trials (Phase 1-4) ongoing, which is great news!
Dr. Baldassano indicated CHOP has identified a protein specific to pediatric IBD and they are now studying it as a treatment target.
Dr. Baldassano discussed diet as being a part of the pathogenesis of the disease. He presented a study showing our Western microbiomes are pro-inflammatory unlike the microbiomes of children in rural Africa, which are strongly anti-inflammatory.
He cautioned against high salt intake as well as high red and processed meat intake. He also presented information on emulsifiers being harmful.
Exclusive Enteral Nutrition is preferred over steroids, with a few exceptions, such as where acute severe inflammation has to be treated quickly. This is for Crohn’s (regardless of disease location) but not UC.
Dr. Albenberg and the RDs led a breakout on dietary therapy. They discussed EEN and SCD specifically, and presented a case study of each. They say they use SCD more than any other diet. They believe in it— either alone or as an adjunct—and recommend patients raise it with their healthcare providers. Studies show that SCD + Remicade works better than Remicade alone. They did indicate some cases are not well suited for dietary therapy, such as severe complicated disease with malnourishment and growth concerns.
They have a UC Diet study (proprietary diet) which is currently recruiting.
They also have a study of stopping/withdrawal of biologics using dietary therapy (Crohn’s Disease Exclusion Diet). This should be published this year. Dr. Stein, the study lead, said this is being trialed for patients in deep remission once they have finished puberty. So far, we know from other studies that about 50% relapse within 2 years. They are trying to find indicators for who will and will not relapse. He also said the good news is 90% of those who relapse can be re-induced with biologics.
They will be starting to study vagus nerve stimulation (in adults).
Very interesting comment on calprotectin. Dr. Baldassano explained it is an anti-inflammatory so is actually doing a good thing when it is elevated. He says that calprotectin can be inhibited by heavy metals like zinc and copper and so we should be very cautious with vitamins and supplements.
The expert panel indicated no current treatment role for FMT (too early), CBD (too early) or LDN (evidence not supportive).
They discussed their recent study of triple / quadruple antibiotics in refractory UC. They noted that for those who benefit, you know within days. In general, they do use antibiotics as part of IBD treatment and believe they work for some patients.
VEO IBD continues to be an important focus (together with genetics generally) and they are finding even some teens have monogenic disease, although it is still relatively rare. They have cured some of these with stem cell transplants.
Overall, lots of HOPE and PROGRESS!
Notes from 2018 CHOP IBD Day.
- IBD is most likely a spectrum of diseases that have similar symptoms but many underlying causes / mechanisms.
- IBD rates are increasing worldwide, particularly in developing countries as they Westernize, and the highest rates of increase are among children and very young children.
- They have studies underway in their most hard to treat patients of the newer biologics, Entyvio (vedolizumab) and Stelara (ustekinumab). They said that Stelara to date seems to have a good safety profile.
- They presented about integrative health in IBD—an evidence-based approach— including herbs, vitamins and minerals, probiotics, nutrition and mind body practices like yoga (CHOP study ongoing) and acupuncture, aromatherapy, exercise and sleep! I was so happy to see this and they are having an inaugural symposium on these topics on April 8th 2018.
- On the topic of diet, not much was new, but they reaffirmed the problems associated with the Standard American Diet (SAD – ie high in refined sugar and animal fat), they also reaffirmed the benefit of EEN for Crohn’s, noted that emulsifiers and food additives may be harmful, and also identified red meat as a question mark. They seem to favor a Mediterranean-style/anti-inflammatory/semi-vegetarian diet. The DINE-CD study in adults will compare the SCD versus a Mediterranean Diet over a 12 week period. Most importantly, they noted that avoidance of fiber is associated with a greater risk of a Crohn’s flare in a 6 month period.
- They discussed genetics. The younger the onset, the greater the relative importance of genetics versus environmental factors. Primary immunodeficiencies are common in the VEO group. They have treated some rare monogenic (ie one causal gene) IBD in young patients successfully.
- They briefly discussed the microbiome and that this is a very hot area of research (together with genetics). IBD patients have dysbiosis, meaning lower diversity of bacteria, lower abundance of beneficial bacteria, like those that produce anti-inflammatory short-chain fatty acids, and higher relative abundance of pathogenic bacteria, like specific strains of E. Coli. Diet, exercise, probiotics and antibiotics all modulate the microbiome. The key to the future is to identify relevant genes, IBD phenotype, relevant bacteria (or viruses, etc) and design personalized treatments accordingly.
- Anemia is a common problem in IBD. The new ferric carboxymaltose infusion was more effective and had fewer adverse events in studies, and required fewer (1 or 2) infusions.
- The GIs panel and answered questions. Some of you may be interested to know that they were quite negative about CBD. They said they are in touch with colleagues studying it in Colorado and there is no evidence of efficacy and may even be pro-inflammatory. One doctor said quite firmly that when she gets asked about it, she tells patients that she is not doing her job if they need CBD. Another question was about coming off meds once in remission. They said this is possible, but that about 50% relapse, and obviously to do this in very close communication with your GI.
- The day ended with a patient panel – a dozen or so absolutely adorable and brave kids and young adults. They were positive and generally grateful for what IBD has taught them, which was amazing to see. All but two were on biologics. None were on SCD. One was only on EEN. The other was a young man who had been diagnosed at age 3. He did nightly tube feeds for years until about 5 years ago and has been in remission, med free, for those years. There was also a woman pursuing her PhD who said her biggest worry was ensuring she was home from school during her Humira delivery. So, lots of hope out there, whatever the path (meds, diet, etc).
IBD Education Day 2019 Presentations and Handouts from Children’s Hospital of Philadelphia (CHOP) https://www.chop.edu/health-resources/ibd-education-day-handouts
- Getting Specific about Feeding Your Gut, Lindsey Albenberg, DO; Erica Schwab, RD, LDN; Natalie L. Stoner, RD, CSP, LD
- How Will New a Future Therapies Change Our Management of IBD?, Robert N. Baldassano, MD
- IBD Research: The Ultimate Team Sport, Judith Kelsen, MD
- Introduction to Radiology, Ami Gokli, MD
- Medical Therapy for Pediatric IBD: Efficacy and Safety, Máire Conrad, MD
- The Role of Integrative Health in IBD Care, Maria R. Mascarenhas, MBBS