P0816 - Enhanced Clinical and Immune Response in Ulcerative Colitis Patients Through Saffron Intervention: A Multisite Clinical Trial Study

Hassan Ashktorab, PhD¹, Roham Salman Roghani, ², Hassan Salmanroghani, ³, Nasrin Farjana, ⁴, Mudasir Rashid, ⁴, Farshad Aduli, MD⁵, Angesom Kibreab, MD⁶, Laiyemo Adeyinka, MD, MPH, FACG⁵, Suryanarayana Reddy Challa, MD⁵, Philip Oppong-Twene, MD, MPH⁵, Lakshmi G. Chirumamilla, MD⁵, Hassan Brim, PhD^1
1College of Medicine, Howard University, Washington, DC; ²Unversity of California Irvine, Irvine, CA; ³Yazd University, Yazd, Yazd, Iran; ⁴Howard University, Washington, DC; ⁵Howard University Hospital, Washington, DC; ⁶Howard University Hospital, Washington, WA

Introduction: We studied saffron as an additional intervention to improve clinical manifestations of Ulcerative colitis (UC) patients,

Case Description/Methods: This is a study at Yazd University where 27 UC patients were randomly assigned to placebo (n=8), low (n=9, 25 mg), or high dose saffron (n=10, 50mg), two times a day for 8 weeks. Hemoglobin, platelet levels, CRP, ESR, and fecal calprotectin along with clinical data (SCCAI, partial Mayo score, and Hamilton anxiety score) were recorded at baseline and completion of treatment. For validation, we recruited 3 UC patients at Howard University who received 50mg of Saffron twice daily for 8 weeks, two underwent a wash-out period and received saffron for a second cycle. Inflammatory markers, CRP, stool calprotectin, and the cytokines from PMA/ionomycin stimulated PBMCs, at baseline and 8 weeks of Saffron treatment were compared. 16S rDNA analysis was performed on stool DNA for gut microbiome.

Results: In Yazd study of 27 patients, all participants completed the study successfully. The high dose group showed significant improvement in HAM-A score (p=0.001), SCCAI (p=0.04), Partial Mayo score (p=0.01), fecal calprotectin (p=0.009), and CRP (p=0.001) compared to baseline. The low-dose group also improved in HAM-A score (p=0.01; Table 1). No adverse events were reported. In HU data, saffron improved Partial Mayo Score, HRQoL, and HDRS (Hamilton depression rating scale). Pro-inflammatory cytokines TNFα, INFγ, IL-6, IL-2, IL-17a decreased while anti-inflammatory IL-10, TGF-β increased (Fig 1). Fecal calprotectin levels of 228 µg/g and 169 µg/g decreased to 63 µg/g and 16 µg/g in two individual patients, respectively. After the wash-out period, fecal calprotectin increased. A second saffron treatment cycle reduced it again further validating the causal relationship. Saffron led to a decrease in gamma Proteobacteria, and enrichment in Ruminococcaceae.

Discussion: This study demonstrates that saffron led to improvements in clinical response including a reduction in partial Mayo scores, HDRS scores, and inflammatory markers such as fecal calprotectin and CRP. These findings suggest that the use of saffron supplements alongside standard treatment protocols may yield beneficial effects for individuals with UC.




Disclosures:


Hassan Ashktorab, PhD¹, Roham Salman Roghani, ², Hassan Salmanroghani, ³, Nasrin Farjana, ⁴, Mudasir Rashid, ⁴, Farshad Aduli, MD⁵, Angesom Kibreab, MD⁶, Laiyemo Adeyinka, MD, MPH, FACG⁵, Suryanarayana Reddy Challa, MD⁵, Philip Oppong-Twene, MD, MPH⁵, Lakshmi G. Chirumamilla, MD⁵, Hassan Brim, PhD¹. P0816 - Enhanced Clinical and Immune Response in Ulcerative Colitis Patients Through Saffron Intervention: A Multisite Clinical Trial Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.