Designing clinical trials centered around food and diets can be difficult. Yet, with nearly 20% of US adults believing that they have food allergies, the need for these studies is larger than ever. As research in this field has advanced, our understanding of food reactivity has become more nuanced. Studies suggest that food sensitivities (or food intolerances) may be distinct from food allergies in both symptoms and the underlying immune response. Regardless of category, it's crucial that patients who suspect their diets may be negatively impacting their health can receive confirmatory testing and diagnosis.
With this goal in mind, Vibrant Wellness recently conducted one of the first clinical trials examining food sensitivity, with results currently in pre-print. The study used innovative peptide microarrays to design personalized elimination diets for each of the 52 participants. Multiple endpoints, including biomarkers and quality of life surveys, were then captured at four weeks to assess the effectiveness of the approach. In this article, we discuss the challenges and insights gleaned during the design and execution of the study, in the hopes of facilitating more clinical trials in this important and emerging field.
Targeted Intervention, Grounded in Data
Food sensitivities, independent of allergies, are estimated to affect at least 20% of the global population. Driven by IgA and IgG antibody responses, food sensitivities cause abdominal pain, bloating, brain fog, joint pain, and other symptoms of chronic inflammation that negatively impact quality of life. Diagnosing food sensitivities is challenging, as these symptoms overlap with a number of other gastrointestinal diseases. Even with appropriate diagnosis, the gradual development of these symptoms over time (due repeat exposure to the offending food), makes it difficult for patients and clinicians to pinpoint the dietary cause.
The current standard of treatment is an elimination diet. The protocol is strict, difficult to adhere to, and the process can take months or even years to complete, as foods are systematically reintroduced in a guess-and-check manner. To address these issues, Vibrant Wellness recently developed a proprietary peptide microarray that can detect IgA and IgG antibodies to 262 peptide and whole protein antigens. This allows clinicians to not only detect food sensitivities, but also definitively inform patients of which dietary components they are sensitive to.
We recently completed a clinical trial designed to determine whether tailored elimination diets (informed by the results of the peptide microarray) were an effective intervention for food sensitivity symptoms. We relied on three different read-outs for assessing the outcomes of this study: a patient completed questionnaire known as the Food Sensitivity-Symptom Severity Scale (FS-SSS), a clinician assigned score on the Food Sensitivity-Global Improvement Scale (FS-GIS), and IgA and IgG antibody titers measured by the Vibrant Wellness peptide microarray.
These read-outs were chosen as they are consistent with measurements used in other clinical trials on food sensitivity and food allergy. By including both patient and clinician assessment of symptoms, we hoped to accurately capture any changes in the patient's quality of life, and antibody titers were included as a quantifiable measurement of the intervention's efficacy. Together, we felt this would give us reliably robust insights for this exploratory clinical trial.
Building a Strong Network
As every scientist knows, science is a team effort. One of the most important components of clinical research is recruiting physicians, clinics, and healthcare professionals willing to support your study and help gather data. To do this, it's crucial to clearly communicate the benefits of your research to clinicians and their patients. For this study, we were able to secure partnerships with providers because we offered access to a technology that addressed an under-served need. Providers were excited to use our peptide microarray to help patients identify the source of their symptoms, which some participants had been dealing with for years.
By clearly demonstrating this benefit, our study was able to secure collaboration with eight different practices across the United States. Practices were chosen based on locations that could provide a representative cross-section of country demographics, as well as locations with a dedicated contact point for trial coordination and managing logistics. This sole point of contact was invaluable for our team, as it allowed us to have constant, two-way conversations throughout the study. It's hard to overstate the value of clear and open communication with providers and their practices. Whether it's recruiting patients, collecting data, or ensuring providers are equipped with the appropriate supplies, clinical trials live and die on the strength of the communication between research teams.
Unique Challenges of Food Sensitivity Studies
We faced several unique challenges when designing our clinical trial. Participant adherence to clinical trial interventions must always factor heavily into trial design. This was particularly important for our diet-based intervention, as we knew that a longer study would increase the likelihood of deviations and potential re-exposure to inflammatory dietary components. However, we needed to ensure that our trial allowed enough time for interventions to demonstrate results, in both symptoms and antibody titer. For example, IgG has a half-life between 15 and 30 days, depending on sub-type. After discussion, four weeks was chosen as the duration that would effectively balance these competing needs.
Another difficult decision centered around the use of a control group. One of the criteria for enrollment in our clinical trial was that patients were presenting with GI symptoms and distress. As participants in this study, they were tested for food sensitivity using our proprietary peptide microarray. After being notified that they had reactive antibodies to dietary components, we felt it would have been unethical to ask that they continue consuming those foods. While broad, non-specific elimination diets were also considered, we felt patient participation and retention would have suffered due to the difficulty of adhering to such a strict diet. For these reasons, we chose not to include a control group in our study, which added to the complexity of interpreting our data but was the correct decision for patient well-being.
“Trade-offs will always be necessary in clinical trials, and the safety, health, and satisfaction of those involved should be prioritized.”
As we continue to explore the emerging field of food sensitivity, I hope that the success of this study prompts future studies with longer observation periods, supplemental data on gut microbiota, and larger cohorts. It's important to recognize that trade-offs will always be necessary in clinical trials, and the safety, health, and satisfaction of those involved should be prioritized. Vibrant Wellness is excited to continue pioneering and publishing studies in this space that lead to meaningful symptom relief for patients and allow providers to offer the best in food sensitivity care.