P0962 - Improvement in Disease-Related Biomarkers With an Adjuvant Treatment for 180 Days: Results From an Interventional Trial for Patients With Ulcerative Colitis

Kara J. Jencks, MD¹, Danielle K. Turgeon, MD², Ryan W.. Stidham, MD², Shannon D. McClintock, ³, Ron Allen, PhD, MS³, Gillian Moraga, ³, Isabelle Harber, ³, Molly M. McNeely, MD², James Varani, PhD², Muhammad N. Aslam, PhD^2
1Mayo Clinic, Rochester, MN; ²Michigan Medicine, Ann Arbor, MI; ³University of Michigan, Ann Arbor, MI

Introduction: Inflammation and colon mucosal barrier defects are manifestations of ulcerative colitis (UC). Drug AQ, a calcium-, magnesium-, mineral-rich product from red marine algae, has been found to improve the barrier structure/function and reduce inflammation. This study aims to investigate whether drug AQ can improve disease-related biomarkers in UC patients.

Methods: In a randomized controlled trial, patients with UC (in remission or with mild-to-moderate disease) were assigned either a placebo or Drug AQ. After 90 days, the placebo group (16 subjects) crossed over to Drug AQ for 90 days. Drug AQ group (12 subjects) stayed on Drug AQ for 180 days. Drug AQ provided 800 mg of calcium plus trace minerals per day. Flexible sigmoidoscopies were performed at days 0, 90, and 180 to obtain stool samples and colon biopsies. Serum samples were also obtained for biomarker assessments. All analyses are based on pre- and post-comparison.

Results: The results showed that C-reactive protein (CRP) and Alkaline Phosphatase (ALP) levels decreased by 23.6% and 9.1% respectively (p=0.005) in subjects who received AQ for 180 days. Conversely, these levels increased by 5% and 3% in subjects on PL. Intestine-specific ALP (iALP) levels decreased by 10.4% in AQ subjects. Eight subjects had ALP levels above the upper range (100U/L). Among those, 3 were on AQ and 5 were on PL. The levels of iALP decreased by 27% (p=0.049) in the three AQ subjects, while iALP increased by 27% in subjects on PL. When pre-post differences in these subjects were compared for iALP, values in the AQ group were significantly lower than in the PL group (p= 0.0187). In addition, fecal calprotectin decreased by 29% in AQ subjects and increased by 43% in PL subjects from baseline. On proteomic screen, AQ upregulated multiple proteins involved in epithelial differentiation and barrier formation. Several proteins with anti-inflammatory, antioxidant, and anti-microbial activity were also induced by AQ, while proteins with pro-inflammatory activity were downregulated.

Discussion: Preliminary data suggests that AQ has the potential to improve the effectiveness of treatments for UC by mitigating disease biomarkers and upregulating gut barrier proteins. Additionally, these findings indicate that AQ can be used as a low-cost and non-toxic adjuvant therapy for mild-to-moderate disease. However, a larger and longer trial is needed for validation.


Disclosures:


Kara J. Jencks, MD¹, Danielle K. Turgeon, MD², Ryan W.. Stidham, MD², Shannon D. McClintock, ³, Ron Allen, PhD, MS³, Gillian Moraga, ³, Isabelle Harber, ³, Molly M. McNeely, MD², James Varani, PhD², Muhammad N. Aslam, PhD². P0962 - Improvement in Disease-Related Biomarkers With an Adjuvant Treatment for 180 Days: Results From an Interventional Trial for Patients With Ulcerative Colitis, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.