For a disease that’s called Inflammatory Bowel Disease, one would think the medical community would spend more time studying the effects that food entering the bowel has on the disease itself.
Well, finally, they are…thanks to ImproveCareNow and a brave doctor leading the charge, a large-scale nutritional research study will launch by the end of July.
Keep in mind that if it’s scientifically proven that diet and nutrition play a role in the healing of IBD, it smacks right in the face of the powerful and wealthy pharmaceutical industry, which venture to gain nothing financially. Right now, there are 177 pharmaceutical products worldwide meant for the treatment of Crohn’s disease and 52 pharmaceutical products in the trial for the same.
“For a long time, we just looked at IBD as primarily a disorder of the immune system, and we forgot the rest of the body, but that’s changing.” – Dr. David Suskind
Standard IBD treatment includes medications that suppress the immune system and dampen the disease’s effects. But those medications leave patients vulnerable to infections and increase the risk of diabetes and other serious conditions.
Dr. David Suskind, who is spearheading some of the first research on children for an innovative diet – called “the Specific Carbohydrate Diet” (SCD) – conducted one of the first studies on the effects of the SCD Diet on IBD.
“The SCD eliminates most grains and sugars, and many of our patients have had tremendous success with it, but no one fully understands why it works or what the best combination of foods is,” Suskind says. “We want to answer those questions and potentially help more children with IBD reduce their medications or stop taking them entirely.”
Suskind’s first study, completed at Seattle Children’s Hospital in conjunction with Children’s Health Care of Atlanta – GI Care for Kids and published in the Journal of Clinical Gastroenterology, examined the effects of the SCD diet on 12 patients. Patients started SCD with follow-up evaluations at 2, 4, 8, and 12 weeks. Eight out of the ten patients who finished the 12-week study showed significant improvement and achieved remission from the dietary treatment alone.
“For decades or longer, medicine has said diet doesn’t matter, that it doesn’t impact disease,” Suskind said. “Now we know that diet does have an impact, a strong impact. It works, and now there’s evidence that it can move patients into remission.”
Suskind suspects that IBD is caused when the immune system reacts to unhealthy bacteria in the microbiome – the bacterial community in the gut and intestine. He hypothesizes that the SCD feeds the beneficial bacteria while starving out the bacteria that contribute to IBD.
Suskind, as part of the ImproveCareNow (ICN) team, are preparing to launch a much larger potentially groundbreaking new SCD Study called the PRODUCE study. “We’re hoping to show exactly how the diet changes the microbiome and quiets down the immune system,” Suskind says.
What is the PRODUCE Study?
The PRODUCE Study, which stands for Personalized Research on Diet in Ulcerative Colitis and Crohn’s Disease, is a first of its kind when it comes to studying nutrition intervention in inflammatory bowel disease. The study seeks to determine the effectiveness of the SCD diet in reducing symptoms of IBD, compared to a modified form of SCD.
Unlike previous smaller studies, the PRODUCE study involves multiple ImproveCareNow (ICN) centers (12 centers) with 120 patients. The intervention is exclusively dietary.
“The PRODUCE Study is going to be a true game changer in how we view IBD and we how we take care of patients” – David Suskind
Patients will alternate between two different Interventions (strict SCD and a modified version of the diet) for 8 weeks each (going back and forth) for 32 weeks (on an ABAB sequence).
This study is set up to examine both the effect for the individual, as well as on a population level, through what’s called an ‘N-of-1 trial.’
N-of-1 trials are single subject experimental designs where the patient serves as their own control. Treatment is systematically varied over time. So, in other words, the same patient is put on the strict SCD and then the modified version for the 32 weeks (total time of the study is 34 weeks, giving 2 week as a preparation time).
“By using an N-of-1 approach, we will be able to generate evidence about the effectiveness of diet in managing IBD for the broader patient community and also, provide direct benefit to patients by giving them greater personal certainty about their treatment choices. This has tremendous potential to improve individual health in a way that is truly personalized and patient-centered.” Dr. Heather Kaplan, Principal Investigator.
Here are the basics of the Study:
- Patients will enter the study on an unrestricted diet.
- They will be randomized to either the SCD or liberalized SCD as their starting intervention.
- Patients will alternate between these two conditions for four 8-week treatment periods.
- Total time in the study will be 32 weeks.
There will be certain criteria that must be met in order to be accepted into the study, which are being defined.
The Improve Care Now is sponsoring the PRODUCE study. This research study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award. ImproveCareNow is an organization working to improve care, focus in quality improvement for all children and youth with Crohn’s disease and ulcerative colitis.