DoD Awards $11M for Novel Ulcerative Colitis Trial Combining Biologic with Plant-Based Nutraceutical
核心洞察
The U.S. Department of Defense (搜索) has awarded up to $11 million to fund a clinical trial investigating the combination of vedolizumab with CurQD (搜索), a plant-based formulation containing curcumin and QingDai (搜索), for ulcerative colitis (搜索) treatment.
The trial addresses the significant burden of ulcerative colitis (搜索) in military populations, where incidence rates are nearly 50% higher than in the general population, affecting over 35,000 military healthcare beneficiaries.
Current ulcerative colitis (搜索) treatments plateau at approximately 50% response rates, prompting researchers to explore whether combining pharmaceutical and nutraceutical approaches may improve patient outcomes.
The U.S. Department of Defense (搜索) has awarded up to $11 million in funding for a groundbreaking clinical trial that will investigate combining a biologic medication with a plant-based nutraceutical formulation for treating ulcerative colitis (搜索). The trial, led by researchers at Mount Sinai Hospital in collaboration with the University of Chicago Medicine (搜索) and Sheba Medical Center in Israel, received an initial $800,000 planning grant with potential for full funding completion.
The DoD's substantial investment reflects the disproportionate burden ulcerative colitis (搜索) places on military personnel. More than 35,000 military healthcare beneficiaries suffer from either ulcerative colitis or Crohn's disease (搜索), with the incidence rate of ulcerative colitis in the U.S. military nearly 50% higher than in the general population. Environmental exposures unique to military service may contribute to this elevated risk, according to the grant application researchers.
Addressing Treatment Response Limitations
The trial will evaluate CurQD (搜索), a proprietary plant-based formulation developed by Evinature (搜索) that combines curcumin and QingDai (搜索) (indigo naturalis), used alongside vedolizumab, an established biologic prescribed for managing ulcerative colitis (搜索) and Crohn's disease (搜索).
The study's rationale stems from a persistent challenge in inflammatory bowel disease (搜索) research: response rates for ulcerative colitis (搜索) treatments typically plateau at approximately 50% in clinical trials evaluating individual drug-based approaches. This ceiling has prompted researchers to explore whether combining pharmaceutical and nutraceutical approaches—each working through different mechanisms—may lead to improved outcomes.
"One of several factors that is motivating us to explore this type of innovative combination is that we believe that patients are quite interested in the idea of using a non-pharmacological complementary approach to support the effectiveness of their care," said Dr. Ryan Ungaro, director of clinical research in gastroenterology at Mount Sinai and principal investigator of the trial. "In essence, what we are trying to do here is to see if we can potentially improve that percentage [of responders] with different complementary approaches."
Evidence-Based Nutraceutical Foundation
CurQD (搜索) demonstrated efficacy in a randomized, double-blinded, placebo-controlled trial in patients with active ulcerative colitis (搜索), published in Clinical Gastroenterology and Hepatology in 2024. The formulation combines curcumin, known for its anti-inflammatory properties, with QingDai (搜索) in a proprietary blend designed to support the body's natural process of returning the gut to baseline and promoting digestive equilibrium.
The nutraceutical is positioned as a complementary formulation intended to work alongside conventional pharmaceutical approaches rather than replace them. This positioning aligns with the DoD-funded trial's objective of studying how a nutraceutical and biologic may complement each other to support improved outcomes.
Notably, CurQD (搜索)'s compounds—curcumin and QingDai (搜索)—were included in the European Crohn's and Colitis Organisation's 2025 consensus guidelines on dietary management of IBD as recommended adjunctive considerations, representing growing recognition of nutraceuticals' role in supporting individuals managing chronic bowel challenges.
International Research Collaboration
The trial brings together three leading institutions in gastroenterology and IBD research: Mount Sinai New York, University of Chicago Medicine (搜索), and Sheba Medical Center in Israel. This international collaboration reflects the study's significance in advancing ulcerative colitis (搜索) treatment approaches.
"This landmark trial is unique in addressing a novel combination strategy for patients with ulcerative colitis (搜索), namely, rather than combining two pharmaceuticals, we will test the combination of a pharmaceutical with a plant-based nutraceutical for improving induction and maintenance of remission over giving the pharmaceutical alone," said Prof. Shomron Ben-Horin, M.D., Chief of the Gastroenterology Department at Sheba Medical Center and Medical lead at Evinature (搜索).
Nir Salomon, founder and director of the Integrative Gastroenterology Unit at Sheba Medical Center and co-founder and Head of R&D at Evinature (搜索), emphasized the patient-centered approach: "This approach, not only may have superior results for patients as we daily see in clinics, but also addresses patients' wishes to harness nutritional support with plant-based natural compounds to improve their gut condition."
Disease Burden and Economic Impact
Ulcerative colitis (搜索) is a chronic inflammatory condition of the large intestine that can cause debilitating symptoms, significantly impair quality of life, and lead to disability. An estimated 1.25 million Americans are living with ulcerative colitis, with the U.S. among the highest prevalence rates globally. The condition most commonly peaks between ages 15 and 30, impacting patients during their most productive years.
The annual economic burden of IBD in the U.S. is estimated at $14.6 to $31.6 billion, underscoring the urgent need for continued research into new treatment approaches. The DoD's investment in this novel combination strategy represents a significant commitment to addressing both the clinical and economic challenges posed by ulcerative colitis (搜索), particularly in military populations where the disease burden is disproportionately high.