Impact report

Advancing New Therapies

Research to uncover new treatments and bring us closer to cures

New Smart Pill Delivers Targeted Treatment

High-tech capsule is programmed to travel to where patients need it most.

Most currently available IBD medications need to reach the intestine to be effective, but to get there they first must make their way through the bloodstream, which can impact other organs and lead to unwanted side effects. A new “smart pill” aims to deliver medicine directly to the colon, which would increase efficacy while minimizing absorption into the bloodstream and related side effects.

This device—also known as a drug delivery system capsule—is being developed by Biora Therapeutics, a biotechnology company. Using funding from our venture philanthropy program, IBD Ventures, Biora Therapeutics will test whether this smart pill can be used to deliver medication directly to the colon of ulcerative colitis patients.

This pill, which contains a tiny computer chip, can be loaded with medication and programmed to travel to the cecum (first part of the large intestine or colon). Once it reaches its targeted destination, it uses a mini syringe or piston to release the drug.

Biora Therapeutics has already demonstrated, using imaging studies, that a version of this smart pill works in healthy people. Thanks to the Foundation’s IBD Ventures program investment, they are now testing a smaller, upgraded version in healthy people and will soon test it in ulcerative colitis patients.

New Smart Pills could deliver medication directly to the colon of ulcerative colitis patients.

New Smart Pill Delivers Targeted Treatment

High-tech capsule is programmed to travel to where patients need it most.

Most currently available IBD medications need to reach the intestine to be effective, but to get there they first must make their way through the bloodstream, which can impact other organs and lead to unwanted side effects. A new “smart pill” aims to deliver medicine directly to the colon, which would increase efficacy while minimizing absorption into the bloodstream and related side effects.

This device—also known as a drug delivery system capsule—is being developed by Biora Therapeutics, a biotechnology company. Using funding from our venture philanthropy program, IBD Ventures, Biora Therapeutics will test whether this smart pill can be used to deliver medication directly to the colon of ulcerative colitis patients.

This pill, which contains a tiny computer chip, can be loaded with medication and programmed to travel to the cecum (first part of the large intestine or colon). Once it reaches its targeted destination, it uses a mini syringe or piston to release the drug.

Biora Therapeutics has already demonstrated, using imaging studies, that a version of this smart pill works in healthy people. Thanks to the Foundation’s IBD Ventures program investment, they are now testing a smaller, upgraded version in healthy people and will soon test it in ulcerative colitis patients.

New Smart Pills could deliver medication directly to the colon of ulcerative colitis patients.

Making Progress on a Test that Predicts Disease Course

PRECIOUS study has met half its recruitment goal.

When patients are first diagnosed with IBD, they have no idea what the future might hold for them. Will their condition remain mild? Or will they face frequent flares and related complications? A new blood test, called PredictSURE IBD, appears to be able to predict which patients are at high risk of having multiple relapses within the following 12-18 months. Research conducted in Europe suggests that this test is highly accurate, and so we need proof that it works just as well in a more diverse group of patients.

Thanks to Foundation funding, a U.S.-based trial called PRECIOUS (Predicting Crohn’s & Colitis Outcomes in the United States) is well on its way. PredictImmune, the company that developed the test, has recruited 93 patients into this study (roughly half of its recruitment goal), 28 of whom have completed more than one year of follow-up. Fifteen practice sites, many of which are part of the Foundation’s Clinical Research Alliance, are currently recruiting additional participants. The investigators expect PRECIOUS to be completed by June 2023.

The PredictSURE IBD test is designed to predict whether a patient is at high risk for multiple relapses.

Making Progress on a Test that Predicts Disease Course

PRECIOUS study has met half its recruitment goal.

When patients are first diagnosed with IBD, they have no idea what the future might hold for them. Will their condition remain mild? Or will they face frequent flares and related complications? A new blood test, called PredictSURE IBD, appears to be able to predict which patients are at high risk of having multiple relapses within the following 12-18 months. Research conducted in Europe suggests that this test is highly accurate, and so we need proof that it works just as well in a more diverse group of patients.

Thanks to Foundation funding, a U.S.-based trial called PRECIOUS (Predicting Crohn’s & Colitis Outcomes in the United States) is well on its way. PredictImmune, the company that developed the test, has recruited 93 patients into this study (roughly half of its recruitment goal), 28 of whom have completed more than one year of follow-up. Fifteen practice sites, many of which are part of the Foundation’s Clinical Research Alliance, are currently recruiting additional participants. The investigators expect PRECIOUS to be completed by June 2023.

The PredictSURE IBD test is designed to predict whether a patient is at high risk for multiple relapses.

Improving Quality of Life and Driving Toward Remission

Initiatives to inform and support clinicians, patients, and caregivers

Confident Patients, Better Outcomes

Study finds that high health confidence is linked to lower risk of flares and steroid use.

When a patient leaves a doctor’s office or is discharged from the hospital, one simple question might shed light on how they’ll fare in the future: “How confident are you that you can manage your IBD?”

New Foundation-funded research suggests that this question, which is a measure of “health confidence” (a patient’s belief in their ability to manage or control their condition), is directly linked to better health outcomes. The study, recently published in our Inflammatory Bowel Diseases journal, is based on more than 17,000 surveys of IBD patients at 27 gastroenterology practices that participate in IBD Qorus, our national quality of care collaborative.

The study reveals that there was a strong association between health confidence scores and measures of disease activity: Patients with “high” health confidence (defined as at least an 8 out of a maximum score of 10) are significantly less likely to have a flare within the following six to 12 months. They are also less likely to use steroids or opioids during that time.

“Whether patients feel like they can handle their disease impacts so much,” says lead study author Chung Sang Tse, MD, of the University of Pennsylvania. “Assessing confidence also presents an opportunity for providers to intervene, such as by directing patients with low confidence to education resources that can help inform and empower them.”

Of course, health confidence can fluctuate, and patients who started with low disease activity are generally more apt to report high levels of confidence later. But even after the researchers adjusted for baseline disease activity, they determined that those who were in the most confident group were 15% less likely to flare during the study period.

“Is it a self-fulfilling prophecy? There may be some of that, but that’s the thing with health behaviors,” says Tse. “If you believe you can do it, you’ll be more apt to do the things that help you succeed,” such as take your medications as prescribed and show up for checkups and important tests like colonoscopies. “It’s more than just wishful thinking.”

Chung Sang Tse, MD, University of Pennsylvania

Confident Patients, Better Outcomes

Study finds that high health confidence is linked to lower risk of flares and steroid use.

When a patient leaves a doctor’s office or is discharged from the hospital, one simple question might shed light on how they’ll fare in the future: “How confident are you that you can manage your IBD?”

New Foundation-funded research suggests that this question, which is a measure of “health confidence” (a patient’s belief in their ability to manage or control their condition), is directly linked to better health outcomes. The study, recently published in our Inflammatory Bowel Diseases journal, is based on more than 17,000 surveys of IBD patients at 27 gastroenterology practices that participate in IBD Qorus, our national quality of care collaborative.

The study reveals that there was a strong association between health confidence scores and measures of disease activity: Patients with “high” health confidence (defined as at least an 8 out of a maximum score of 10) are significantly less likely to have a flare within the following six to 12 months. They are also less likely to use steroids or opioids during that time.

“Whether patients feel like they can handle their disease impacts so much,” says lead study author Chung Sang Tse, MD, of the University of Pennsylvania. “Assessing confidence also presents an opportunity for providers to intervene, such as by directing patients with low confidence to education resources that can help inform and empower them.”

Of course, health confidence can fluctuate, and patients who started with low disease activity are generally more apt to report high levels of confidence later. But even after the researchers adjusted for baseline disease activity, they determined that those who were in the most confident group were 15% less likely to flare during the study period.

“Is it a self-fulfilling prophecy? There may be some of that, but that’s the thing with health behaviors,” says Tse. “If you believe you can do it, you’ll be more apt to do the things that help you succeed,” such as take your medications as prescribed and show up for checkups and important tests like colonoscopies. “It’s more than just wishful thinking.”

Chung Sang Tse, MD, University of Pennsylvania

Making Strides in Diet and Nutrition Research

A study is investigating the impact of specific foods on the microbiome; another is testing a diet designed to keep kids in remission.

One of the first questions newly-diagnosed patients ask is, “What should I eat?” Right now, there are few clear answers, but Foundation-supported studies are bringing us closer to new insights about using diet as an adjunct to medication for controlling IBD.

Thanks to a grant from our Precision Nutrition initiative, researchers at the University of California, San Diego have completed the first phase of a project that explores the connection between the foods people eat, the microbiome in the gut, and IBD disease activity. The scientists use machine learning technology to generate "food-specific metabolomic signatures" for thousands of popular foods, so they can now determine which foods someone has consumed by analyzing the metabolic end products that appear in their body after digestion. They also found that certain foods were associated with less diversity of gut microbes and more severe disease. The next step will be to corroborate these findings, which would support future studies designed to evaluate a new dietary intervention for people with IBD.

Other Foundation-funded research, at Scotland’s Glasgow University, is focusing on children who reintroduce solid foods into their diet after reaching remission on an exclusively formula-based, liquid diet (enteral nutrition). The goal is to identify triggers of relapse so that future patients could be instructed to avoid those foods. They will also identify the immunological and microbiological drivers of relapse in response to these food triggers. Enrollment is underway, with ten leading pediatric IBD centers in Scotland and England participating in this study.

The Precision Nutrition Initiative is made possible by the generous support of Jonathan D. Rose, MD, PhD, Chair of the Crohn’s & Colitis Foundation’s Intestinal Pathology Research Program.

Foundation-funded research could provide insights into how diet might help control IBD.

Making Strides in Diet and Nutrition Research

A study is investigating the impact of specific foods on the microbiome; another is testing a diet designed to keep kids in remission.

One of the first questions newly-diagnosed patients ask is, “What should I eat?” Right now, there are few clear answers, but Foundation-supported studies are bringing us closer to new insights about using diet as an adjunct to medication for controlling IBD.

Thanks to a grant from our Precision Nutrition initiative, researchers at the University of California, San Diego have completed the first phase of a project that explores the connection between the foods people eat, the microbiome in the gut, and IBD disease activity. The scientists use machine learning technology to generate "food-specific metabolomic signatures" for thousands of popular foods, so they can now determine which foods someone has consumed by analyzing the metabolic end products that appear in their body after digestion. They also found that certain foods were associated with less diversity of gut microbes and more severe disease. The next step will be to corroborate these findings, which would support future studies designed to evaluate a new dietary intervention for people with IBD.

Other Foundation-funded research, at Scotland’s Glasgow University, is focusing on children who reintroduce solid foods into their diet after reaching remission on an exclusively formula-based, liquid diet (enteral nutrition). The goal is to identify triggers of relapse so that future patients could be instructed to avoid those foods. They will also identify the immunological and microbiological drivers of relapse in response to these food triggers. Enrollment is underway, with ten leading pediatric IBD centers in Scotland and England participating in this study.

The Precision Nutrition Initiative is made possible by the generous support of Jonathan D. Rose, MD, PhD, Chair of the Crohn’s & Colitis Foundation’s Intestinal Pathology Research Program.

Foundation-funded research could provide insights into how diet might help control IBD.

Improving Access to Care

Breaking down barriers to optimal care for everyone with IBD

Removing Obstacles to Treatment

Study confirms that insurance protocols are often detrimental to patients.  

Gastroenterologists have long complained that health insurance protocols frequently lead to treatment delays and poorer health outcomes for IBD patients. Now we have objective proof of the detrimental impact of these obstacles.

As many IBD patients know all too well, getting started on the proper therapy isn’t as simple as having a doctor write the prescription. Most health insurance companies require that providers first obtain prior authorization for certain drugs. They also often insist that patients try and fail less expensive treatment before agreeing to cover the requested medication, a practice known as mandated step therapy, or “fail first.”

In a new study, sponsored in part by the Crohn’s & Colitis Foundation and published in the journal Pediatrics, researchers studied the link between prior authorization protocols and patient outcomes in 190 children with IBD who were on biologic drugs.

The researchers assessed whether differences in insurance protocols that preceded the initiation of the desired biological therapy were associated with how the children were faring 6 months later.

The findings revealed that it took, on average, 21 days for a patient to start the desired biologic from the time the physician and patient (or patient’s parents) decided to try it. If prior authorization was needed, biologic initiation didn’t start until an average of 31 days. And, if it was deemed “complicated”—meaning it entailed an appeal, mandated step therapy, or peer to peer review—patients didn’t start the treatment until about day 36.

These delays had serious ramifications: Patients who had to wait for prior authorizations were 13% more likely to visit the emergency room, be hospitalized, or require GI surgery within six months from the time the study began. They were also 14% more likely to be dependent on steroids at that point.

The problem, says study co-author Frank I. Scott, MD, assistant professor at the University of Colorado Anschutz Medical Campus, is that these insurance-related delays meant that many patients were in the midst of a major flare by the time they got the green light to start a biologic.

Scott also noted that all the prior authorization requests for patients in this study were eventually granted, which suggests that insurers were simply delaying the inevitable.

“The goal of this study, and others focusing on adults, is to show the insurers that you can kick the can down the road, and delay maybe one or two doses to the next fiscal year, but you’ve also triggered downstream medical events that are almost certainly more expensive than delaying those one or two doses,” says Scott.

“The study provides us with clear evidence of how “fail first” protocols can endanger the health of IBD patients who really need to receive their prescribed medication at the time of the prescription,” says Caren Heller, MD, MBA, Chief Scientific Officer of the Crohn’s & Colitis Foundation. “We will continue to fight for step therapy reform to ensure that critical decisions about prescribed medications remain between doctors and their patients.”

Help us advocate for prompt, excellent care.
The Crohn’s & Colitis Foundation and our tireless volunteers have played an integral role in getting mandated step therapy reform legislation passed in 31 states. We’re now working toward passing national legislation via the Safe Step Act. Learn more and find out how you can help by visiting Step Therapy.

Frank I. Scott, MD, assistant professor at the University of Colorado Anschutz Medical Campus