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Microbiome Progress for Patient Treatment Begins with Research
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As patients within gastroenterology become savvier in management of their diseases – notably with inflammatory bowel disease and irritable bowel syndrome – it is likely physicians will more and more frequently field questions about the role of the microbiome in disease and symptom management.
I get questions regularly as this area of research has reached the level of awareness of the average IBD patient. Many patients are very intrigued by the role of the microbiome in IBD.
They have heard about fecal transplants for IBD and may have gotten mixed messages about the efficacy. They come in hoping they can undergo fecal microbiota transplantation, but we have to redirect them since the only current indication is for recurrent Clostridium difficile infection. Unless FMT is used in the context of a clinical trial, most gastroenterologists are not doing this for IBD or any other GI disorder. Patients also ask about probiotics as an option to alter their microbiome.
The concept and the science of microbial changes leading to various diseases, including IBD, is still in its infancy. The capabilities are not yet there to reliably analyze the microbiome in the everyday patient. Right now, we are still having basic chicken-and-the-egg conversations – is it the inflammation in IBD that changes the microbiome or is it the microbiome change that causes the inflammation in IBD?
It’s wonderful that centers like PennCHOP’s Microbiome Center, on which we focus this month’s pictorial, are doing these studies, but even they will tell you it may be some years before we see this in clinical practice. For me, the ideal IBD visit would include a blood test for genetics immunoprofiling to tell me which biologic mechanism of action this patient will be most responsive to and then a stool test that tells me if a patient is deficient in certain bacteria, which we could then replace with either dietary changes or a microbiome-derived treatment.
Perhaps it is my bias as a clinician and a clinical trialist, but I am carefully watching the companies that are developing microbiome-derived products with pharmaceutical grade purity. Companies like Seres Therapeutics, which has a product being studied in C. diff and IBD, are trying to take their best guess at the 50 or 100 most important bacteria that might be protective. With those educated guesses, we are starting to see these very early phase 1 and 2 studies exploring the efficacy of microbiome-derived products.
For the average clinician, the confirmation of dietary effects on the microbiome are also still part of the long game for clinical treatment. It’s great that we are seeing actual studies of diet, such as the DINE-CD study comparing a Mediterranean to the specific carbohydrate diet for patients with mild-to-moderate Crohn’s disease. This study, sponsored by the Crohn’s & Colitis Foundation, and others happening at centers like PennCHOP, will move the needle on our knowledge about how diet impacts the microbiome.
It’s in these studies where experts like Gary Wu, Rick Bushman, David Baldassano and James Lewis, will help us find the actual impact. We all hypothesize that diet must play a role in disease and that diet likely mediates its role through the microbiome. Still, at the moment, it is difficult to provide diet advice and expect to have an impact in the patient’s microbiome in a way that improves their disease state.
This is an exciting new avenue of research. It may explain not only obvious culprits like IBD but may also explain IBS or other systemic diseases. If you’re interested in microbiome research, I encourage you to get involved with clinical trials and watch the great work centers like these are doing for our patients.
Disclosure: Loftus reports consulting for Janssen, Takeda, AbbVie, UCB Pharma, Amgen, Pfizer, Celgene, Gilead, Eli Lilly, CVS Caremark, Celltrion Healthcare, and Napo Pharma; and research support from Janssen, Takeda, AbbVie, UCB Pharma, Amgen, Pfizer, Celgene, Gilead, Robarts Clinical Trials, MedImmune, Allergan, Genentech, and Seres Therapeutics.