It might sound like science fiction, but we’re using stem cell technology to grow three-dimensional “mini guts” in laboratory micro-engineered chips as the basis of our Fibrosis Initiative, a multi-disciplinary collaborative study investigating the biological mechanisms of fibrosis in IBD. Also known as “gut on a chip” or “human organoids,” the mini gut models are enabling scientists to learn more about the role that genes and other factors play in the development of fibrosis.

Fibrosis, which is a buildup of scar tissues in the intestines, is a common complication that can lead to surgery. Thanks to funding by the Foundation, researchers at Cedars Sinai have been refining this technology and recently published a proof-of-concept study in Inflammatory Bowel Diseases® (IBD Journal) proving that they can create personalized mini guts from any patient using “induced pluripotent stem cells.” This is the first publication funded through our Fibrosis Initiative.

Pluripotent stem cells have the potential to turn into any type of cell in the body. Until recently, many scientists believed that only embryonic stem cells had this capability. Robert Barrett, PhD, and Stephan Targan, MD, used a grant from the Foundation to develop an unprecedented methodology: They can now take blood samples from an adult patient, extract stem cells from their blood, induce those stem cells to convert to a pluripotent (embryonic) state, and use them to create mini guts that match the genetics of that same patient.

Barrett and Targan have also been able to induce fibrosis in the mini gut model by exposing the cells to an inflammatory cytokine (protein) called TGF-beta.

This research will enable scientists to learn more about the mechanisms that cause fibrosis and ideally one day help them explain why certain patients are prone to it. “It also opens the door for precision medicine,” says Barrett. After growing a mini gut of a particular patient, doctors could evaluate different anti-fibrotic therapies in the mini gut model to see which one would likely produce the best response if prescribed to the patient.

“Our findings mark a major step forward in addressing the mechanism of fibrosis in IBD,” says Barrett. “This research would not have been possible without the Crohn’s & Colitis Foundation. They inspired a completely new line of inquiry for my lab and gave us the perfect opportunity to apply our technology to address this vexing problem for IBD researchers, specialists, and patients. We look forward to using these mini guts for many future investigations into the causes of and treatments for fibrosis.”

This project is generously supported by Jonathan D. Rose, MD, PhD as part of the Jonathan D. Rose, MD, PhD, Crohn’s & Colitis Foundation / Cedars-Sinai Pathology in Precision Medicine Research Collaborative.

The field of inflammatory bowel disease (IBD) research has advanced exponentially in recent years, yet many questions remain unanswered. How do we precisely match children with IBD to the right medication more quickly? Why do so many Crohn’s disease patients eventually require surgery, and how can we predict those patients at highest risk for post-surgery complications or disease recurrence? These are crucial knowledge gaps we aim to address with the creation of two brand-new research projects: CAPTURE IBD and IBD SIRQC.

CAPTURE IBD and IBD SIRQC are forward-looking cohort studies. A cohort study is a type of observational study in which researchers follow participants over an extended period of time. Data from both of these will feed into IBD Plexus®, our interconnected big data platform.

Advancing Precision Medicine in Children

Unfortunately, much of the care provided to kids with IBD has been based on what we’ve learned by studying adults. We need more pediatric-specific research to develop best practices for kids. CAPTURE IBD (Cohort for Pediatric Clinical and Translational Research in IBD) is poised to become a robust repository of data on children ages 4–21 with IBD. CAPTURE builds on the highly successful Pediatric RISK Stratification Study, which identified a biological signature that could predict whether a child newly diagnosed with Crohn’s disease would develop serious complications.

While the RISK study was limited to Crohn’s disease, CAPTURE will also include children with ulcerative colitis. CAPTURE’s ultimate goal is to advance precision medicine by matching distinct subgroups of patients to the specific drug therapy or therapies most likely to be effective for them.

Participants in CAPTURE will continue receiving their usual care while sharing detailed data about their health along with blood, stool, and tissue samples for use in the study. Researchers will then thoroughly analyze demographic, clinical, and “multi-omics” data (which includes, for example, genomics, and microbiomics) and aim to develop biological signatures that can be used to flag patients as being likely responders or non-responders to specific types of biologic drugs.

CAPTURE is being led by Michael Rosen, MD, at Stanford Medicine and Stacy Kahn, MD, at Boston Children’s Hospital, with a total of 12 pediatric IBD centers participating.

Improving Surgical Outcomes

IBD SIRQC (IBD Surgical Innovation, Research, and Quality Collaborative) is the Foundation’s first-ever surgical research initiative. SIRQC will enroll adults with Crohn’s disease or ulcerative colitis preparing to have GI surgery and will follow them through their surgery and beyond to track long-term surgery outcomes and our understanding of the impact of surgery on IBD including post-procedure complications and disease recurrence.

“SIRQC will help advance the scientific understanding of the impact surgery has on patient outcomes,” says Alandra Weaver, MPH, the Foundation’s Associate Vice President of Clinical Quality and Research Innovation. It also aims to advance precision medicine by identifying factors that can be used to predict who is most likely to remain healthy after surgery and who will need further intervention and treatment. SIRQC is being spearheaded by Stefan Holubar, MD, at the Cleveland Clinic, and Samuel Eisenstein, MD, at UC San Diego Health, with a total of 9 sites (and growing) participating across the country.

Participants in SIRQC will undergo surgery with their participating GI surgeon and give permission to share data and biosamples for analysis.

This project is generously supported by Jonathan D. Rose, MD, PhD.

Biologic drugs are often expensive, even for people who have health insurance. Enter lower-cost biosimilars, which are nearly identical copies of biologic drugs and have equal potential to get patients into remission. Yet many misconceptions about biosimilars persist. To combat them and inform patients, we created multiple online resources and a dedicated MyIBD Learning Webinar on the topic.

Q. Are biosimilars the same as generic drugs?

A. A generic drug contains an exact copy of the chemical compound that comprises the active ingredient of a brand-name drug. Generics are easy to make and are stable, so they can be produced quickly.

A biosimilar is a near identical copy of a brand-name biologic drug (known as the reference product). But it’s impossible for it to be an exact copy because biologics are made from complex proteins derived from living cells. “The manufacturing process for a biologic—and its biosimilar—is far more complex, though the active ingredients are the same,” Christina Ha, MD, of Cedars-Sinai, explained during our webinar. “It takes a long time to develop a biosimilar—up to 7 or 8 years.”

Q. Are biosimilars as good as “real” biologics?

A. “The number of quality assurance tests that need to be done prior to FDA approval [of a biosimilar drug] is much higher than what needs to be done prior to approval of a generic drug,” said Ha. “I think a lot of the concern is due to the fact they’re called biosimilar, not bioexact.” But when comparing a biosimilar to the reference product, “there is no difference in terms of effectiveness, potency, purity, or safety,” she said.

Q. Will I respond the same way to a biosimilar as I did to the biologic?

A. The strength, dosage, storage, and infusion rate or injection process are all the same, so you shouldn’t notice any difference. “Biosimilars are administered exactly the same way as the reference product,” said Ha. “The treatment routines and quality of care should be identical.”

You can learn more and watch the full MyIBD Learning Webinar at Biosimilars: What You Should Know.

Our Visiting IBD Fellow Program is a highly competitive opportunity that enables a select group of gastroenterology fellows to shadow experts at leading IBD centers. During our 2020–2021 cycle, 18 of them completed a one-month virtual rotation at IBD centers across the country. Daniel Castañeda, MD, who completed a virtual rotation at the University of Chicago, shares his experience:

“Despite being virtual, I felt very engaged the whole time. I was assigned to shadow Dr. David Rubin, MD, and Dr. Russell Cohen, MD, who are both renowned leaders in the field. I ‘followed’ them and others on their team by using a tablet. During every single encounter with a patient, I was introduced to that patient, and we’d have a conversation. I was able to ask questions and participate in discussions about diagnosis and treatment options, and after each case we’d debrief. We also reviewed previous patient cases and discussed how they were handled.

One of the most important things I learned was how to really tailor information and treatments to each person with an eye on providing them with the best possible quality of life. Some patients we saw had very complex disease, so we had to consider everything from the use of newer small-molecule drugs to surgical options.

I would say without hesitation it was a great experience. It provided me with mentoring from experts in the field and expanded my knowledge about diagnostic, surveillance, and therapeutic tools for patients with IBD. I want to thank the Crohn’s & Colitis Foundation for giving me this valuable opportunity.”

Additional information is available on our Visiting IBD Fellow Program homepage.

Living with IBD can be challenging for anyone, but children in particular often report feeling isolated or embarrassed as a result of their disease. Camp Oasis, our co-ed residential summer camp for kids with IBD, has frequently been described as life changing—and now we have the data to prove it.

We recently analyzed responses to online surveys completed before and after camp by more than 6,000 people (a mix of campers who participated in Camp Oasis between 2012 and 2019 as well as their parents/caregivers). Their feedback confirmed the power of this program: Ratings provided by campers and their parents/caregivers consistently show very large improvement in openness, confidence, sociability, and more. As you’ll see in the chart below, after camp, the number of respondents who agreed a lot that the campers were “open about their disease with friends” increased by 56% versus surveys submitted before camp. Other measures, such as “Campers were comfortable asking doctors about IBD,” and “Campers were confident after Camp,” showed after-camp increases of 46% and 44% respectively in the “agrees a lot” category.

In the words of one parent, “Camp Oasis has been the most impactful, valued, fulfilling, and fun week of my daughter’s life for the past 6 years. Camp nourishes her soul and gives her confidence. It has taught her to become a fierce advocate for her needs, whether in a school [or] athletic, social, or family environment. She is committed to continuing with Camp Oasis and ultimately would like to become a pediatric gastroenterologist. Camp Oasis has given more to our family than we can ever repay.”

We are grateful to our generous donors who make Camp Oasis possible every year.

The Crohn’s & Colitis Foundation, the leading non-profit dedicated to finding cures for inflammatory bowel disease (IBD) and improving patient quality of life, recently launched the We Can’t Wait app, which provides an interactive map that allows users to find a restroom near them across the U.S. Driven by crowdsourced submissions and major retail and restaurant partners that contributed their restroom location data, the app empowers IBD patients—and all users—with a tool to find restrooms more easily, both in emergency and everyday situations. The app is free and available for download now.

With significant support from lead sponsor Eli Lilly, the We Can’t Wait app helps individuals solve for a significant public health issue: a lack of available public restrooms. Everyone has experienced the challenge of being away from home and needing to use a restroom, but for some people, like IBD patients, quick restroom access is a medical necessity. Many IBD patients experience urgent bowel movements, which can happen unexpectedly at anytime, anywhere. If a restroom isn’t immediately available (or if they are turned away by a business), patients may face debilitating pain, extreme anxiety, and even traumatic bowel accidents.

The We Can’t Wait app is the centerpiece of the Foundation’s Open Restrooms Movement. In partnership with peer healthcare advocacy organizations, we are calling on stakeholders in the public and private sectors to recognize the issue of restroom access as a basic human need and permit public access to restrooms wherever possible. Businesses and governments can help solve this critical scarcity of public restrooms with a simple act of human kindness: opening their restrooms.

“Our patient community has always been vocal about the challenges and frustrations that come with finding a restroom. The Foundation has fought alongside them to ensure patients can achieve the highest quality of life, ” said Michael Osso, President and CEO of the Crohn’s & Colitis Foundation. “By creating resources like the We Can’t Wait app and sparking more conversations about IBD and restroom access, we are working to foster a safer, healthier, and more understanding world for IBD patients.”

On the app, users simply navigate the on-screen map to find a restroom close to their location; they can also submit locations to be added to the map. To kickstart the app’s launch and ensure more businesses will be genuinely welcoming to patients, the Foundation is partnering with major U.S. retailers and restaurants, including the Home Depot and Just Salads, among others. With more than 3,000 partner locations at launch (45,000 total), the Foundation is actively adding restrooms through partnerships and crowdsourcing.

We Can’t Wait builds on the Foundation’s longstanding efforts to ensure restroom access for anyone with a medical necessity. The Foundation’s support for patient advocacy at the state level has helped lead to the passage of the Restroom Access Act (also known as Ally’s Law) in 18 states, which gives patients with certain medical conditions access to employee-only restrooms if a public one is unavailable. While the Foundation has long supported local volunteer efforts at the state level as they promoted this legislation, we find that awareness of the law is very low, and compliance by businesses is still a major issue for patients. The Open Restrooms Movement is another way to help give patients more access to this very fundamental human need.

For more information, please visit our We Can’t Wait: Restroom Access App homepage.

If you’re a veteran with IBD, finding the right information and support can sometimes be challenging. That’s why on Veteran’s Day 2021, we launched a brand-new suite of educational resources on our website, which we kicked off with an informative Facebook Live event (now available as a video on our site) featuring Lieutenant Colonel Joshua Nelson, who has ulcerative colitis, and Meena Prasad, MD, director of inflammatory bowel disease at the Atlanta VA Medical Center.

“Before building this initiative, the Foundation conducted an assessment during which we talked to patients and providers to explore the needs of the veteran community,” says Catherine Soto, the Foundation’s senior director of patient education and support. “We also entered into a partnership with the U.S. Department of Veterans Affairs (VA) in our efforts to engage and support veterans with IBD.”

Our new online resources include tips on how to navigate the VA healthcare system, why you might need a traveling veteran consult (a process that ensures continuous care if you move), and where to find a mental health professional who can help you cope with IBD-related stressors.

Visitors to our site can also view videos including the above-mentioned Facebook event, another featuring Air Force veteran and IBD patient Renee Gaither, and one with Lieutenant Colonel Anish Patel, DO, director of the IBD Center at Brooke Army Medical Center in San Antonio.

As part of this initiative, we’re also now offering a support group option for veterans with IBD. “We wanted to create a space for veterans to come to the Foundation and understand that there are others like them,” says Soto. “The message: You are not alone."

Past Impact & Annual Reports

Read about the advances the Foundation has made in the IBD space.

View our Past Impact Reports