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I have been waiting for this day for a long time. The Crohn’s and Colitis Foundation of America has recently agreed to conduct a comprehensive study/clinical trial to review the effectiveness of the grain free/gluten free Specific Carbohydrate Diet (very similar to the Paleo diet) as a treatment option for Crohn’s Disease.
For those who are not familiar with Crohn’s Disease, it is a chronic and debilitating autoimmune disease affecting over 500,000 Americans. Both the Paleo diet as well as the Specific Carbohydrate diet are popular with the Crohn’s patient community based on individual patient testimonials. However, despite several small studies to date there have yet to be any large scale clinical trials to test diet as a means for helping relieve symptoms of Crohns Disease.
Despite large numbers of patient testimonials and substantial interest in grain free diets for IBD, the medical community has been cautious to recommend any diet as a viable option for Crohns and Ulcerative Colitis patients without studies such as this one proving it’s effectiveness. Until now it has been difficult to find sources of funding for such studies, leading to a chicken and egg type of situation.
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The Study and Funding Details
This landmark study will consist of a 12 week clinical trial comparing patients assigned to a group eating a Specific Carbohydrate Diet (or SCD diet) and a Mediterranean Diet as a control group. The Mediterranean Diet was chosen as a control both because it is generally considered to be a healthy diet by the medical community as well as being considered easier to follow than grain free diets like the SCD and Paleo. In addition there has been some interest of the Mediterranean diet in itself as being helpful for IBD, given it’s emphasis on whole versus refined grains.
The study is being funded by a 2.5 million dollar grant awarded to the CCFA from the Patient Centered Outcome Research Institute (PCORI), a non profit organization created by the U.S. Congress in 2010 as part of the Affordable Care Act. The idea and motivation for the study came out of a Patient Powered Research Network that has been run by the CCFA, known as CCFA Partners. Through the program, patients have been able to help contribute to the pool of knowledge and research about Crohn’s disease by answering surveys about their own health and experiences over time. It also allows participants to contribute and vote on ideas for new research studies, which resulted in the idea for this clinical trial.
How the Study Will Be Conducted
Three meals and two snacks will be provided to participants for the first 6 weeks of the study by the meal delivery service Real Food Works. Meals will be based on the Specific Carbohydrate Diet guidelines for those assigned to the SCD group and based on the Mediterranean diet guidelines for those assigned to that group. After 6 weeks, study participants will be given the option of paying out of pocket for the subsequent 6 weeks of meal delivery through Real Food Works for the remaining half of the study. They will also receive instruction and recipes for preparing meals themselves following their assigned diet, as an alternative to paying for the meal delivery that final 6 weeks if they choose.
The study will be conducted through the University of Pennsylvania Perlman School of Medicine. The Principal Investigator on the project is Dr. James Lewis, Senior Scholar at the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania. In addition, an advisory body made up of both patients and researchers from the CCFA Partners program will oversee both study design as well as collection and dissemination of research results.
What is so Monumental about a Study?
Let me give a little background on why this is such amazing news. For those of us suffering from IBD related diseases such as Crohn’s Disease and Ulcerative Colitis, the Crohn’s and Colitis Foundation is the largest and most well know non-profit organization in the U.S. dedicated to supporting those with IBD. They educate the IBD and medical community about these diseases, help organize support groups for IBD patients, raise awareness about these conditions and raise money for research.
During the past decade, the popularity of those using diet to help with these diseases seems to have continued to only build momentum over time. The Specific Carbohydrate Diet, which was created specifically for those suffering from IBD is one very popular option, as well as it’s offshoots such as the GAPS (Gut and Psychology Syndrome) diet.
With the exploding popularity of the Paleo diet in the last several years, many others with IBD have first been introduced to grain free diets through hearing about the Paleo diet. Many in the IBD community have also seen success with Paleo and have spread the word about how living grain free has helped them. A decent subset of the growing worldwide Paleo community are those with IBD and other autoimmune conditions. For example, Rob Wolf, one of the early proponents of the Paleo diet had used it himself to help with his Ulcerative Colitis. More recently many others have used the AIP (Autoimmune Paleo Diet) to help to control their Crohn’s and Colitis symptoms. All forms of IBD are considered autoimmune diseases.
Why This is a Breakthrough in Paleo/Grain Free Diet Research
Despite this grassroots movement to share successes with these diets, the general literature from the mainstream medical establishment as well as the CCFA has generally been one of caution. I would argue that a number of the articles published by the CCFA in the past went so far as discouraging people from trying these diets (for example these articles and webinars published in previous years from the CCFA: 1, 2).
The general sentiment from the medical establishment for many years about grain free diets like Paleo and SCD has been that there is not enough research to support them. This is despite small studies over the years that showed promise for the SCD diet as a treatment for IBD (1, 2, 3, 4 and 5). Because grain free diets have yet to be proven to work with a clinical trial, patients are generally discouraged from trying them and their safety for patients is questioned.
Although it makes some sense that the pharmaceutical companies that fund research on treatments for autoimmune disease would not be interested in funding research into dietary approaches, this has left a widening gap between those in the IBD community who have seen success with dietary treatments and the recommendations from the medical community and medical literature.
From my perspective, this seems like the perfect role for the CCFA. As a donor funded organization that in its mission statement lists that the “CCFA sponsors basic and clinical research of the highest quality”, the CCFA is not under pressure to sponsor research that will create profitable drugs and treatments. Not being constrained by the goal of profit, they are in a unique position to focus their efforts on encouraging research that is solely motivated by the goal of improving the lives of those suffering from these diseases.
CCFA Partners
More recently, the CCFA had created a “patient powered research network” or PPRN called CCFA Partners. I personally see this as a great step in the right direction. Through an collaborative social website, individuals with IBD have been able to sign up and share their own experiences through surveys and track their disease symptoms over time, with the idea that this information would assist with research. Although I would say that the collaborative features of the website could be improved, it is an opportunity for those in the IBD community to get involved with data gathering about many aspects of living with these diseases.
As a benefit of participating in the PPRN, patients are also able to contribute feedback about research studies for IBD they would hope to be explored in the future. Patients are able to suggest and prioritize future research ideas though an interactive forum. There was a large outpouring of interest in a study exploring diet and the Specific Carbohydrate Diet in particular which helped lead to the motivation for this study.
The Future
My hope is that the future of the IBD community moves in the direction of the stated goals of the CCFA Partner program. I believe that the most positive path forward is for the IBD patient community, the medical community and research community to come together and share information and ideas in both directions. Ideally there would be a free flow of suggestions, ideas and prioritization going from the patient community back to medical professionals, researchers and even drug companies, rather than all information flowing in a top down manner. Putting all of our heads together to come up with solutions that work for people, not just theories in a lab or medical setting, is our best hope for making progress in the future.
I thank PCORI, the CCFA, UNC CCFA Partners team and UPenn for having the foresight to move forward with this study. I cannot wait to hear and write more about the details as the study process unfolds.
In the interim, if you are interested in participating in the study, the CCFA is currently pointing interested parties to enroll in their CCFA partners program, which will eventually be used to as part of this study: http://www.ccfapartners.org/
As we have more information about details about the study and enrolling, we will be sure to publish them here on the blog.
In looking up Real Food Works, the chosen delivery service, it appears they have taken down their website and stopped posting on social media, but others have written about their meal delivery services in the past if you’d like to get a sense of the company.
The lead investigator of the study did the following interview with the CCFA that goes over an update on the logistics of the study (which has been given the acronym DINE-CD):