CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study

NCT ID: NCT07240168

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-07
• Study Completion Date: 2026-08-20

Brief Summary

This study aims to evaluate whether adding CurQD, a nutraceutical composed of Curcumin and QingDai, improves treatment outcomes in patients with active ulcerative colitis (UC) who are already receiving Vedolizumab but still have ongoing disease activity. The study will use de-identified patient records collected through Evinature's global data platform. We will examine whether the addition of CurQD helps patients stay on Vedolizumab longer, improves symptoms and biomarkers, and increases satisfaction with treatment.

Detailed Description

Curcumin and QingDai, (Indigo, QD) are two herbal traditional medicine compounds which have been investigated for their use in mild-moderate and moderate-severe UC, respectively. A combination of Curcumin and QD (CurQD), which was developed at Sheba Medical Center to maximize clinical efficacy while reducing long-term high-dose QD exposure, has been used in clinical practice in Israel since 2015 and has gained wide acceptance by UC patients and IBD experts [1,2]. In two multi-center retrospective studies, CurQD was found effective in inducing clinical and biomarker remission in both adult and pediatric patients, including in patients who were refractory to biologic and/or small molecules [3,4], and recent evidence from a pediatric cohort in the U.S also documented intestinal sonographic response to CurQD [5]. In a placebo-controlled randomized trial from Israel and Greece, CurQD was found superior to placebo in inducing and maintaining clinical and endoscopic remission without any safety signals [6,7]. Moreover, the study also showed the active compounds in CurQD exerts agonistic up-regulation of Aryl-hydrocarbon Receptor pathway in the rectal mucosa [6], supporting its unique non-immunosuppressive mode-of-action. Subsequently, CurQD has been increasingly used by IBD experts in academic centers in the USA and elsewhere as Add-on therapy in patients with partial or non-response to biologics and/or small molecules medications. Recently, CurQD became the first and only nutraceutical to date to pass the CCFA Ingestible committee examination of supporting clinical and scientific data to allow its endorsement by the CCFA. Collectively, these data provide the rationale for exploring large scale population-based impact of combining CurQD with a biologic.

The present retrospective cohort study will interrogate the Evinature GDPR HIPAA compliant database to identify patients who started CurQD while being treated with VDZ. The study will investigate the clinical benefit of adding CurQD in combination with VDZ, in patients partially responding or not-responding to VDZ.

Conditions

Ulcerative Colitis (UC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1 (VDZ + CurQD)

Patients with ulcerative colitis on Vedolizumab who initiated CurQD as adjunct therapy.

CurQD (Curcumin + QingDai combination)

Intervention Type: DIETARY_SUPPLEMENT

Patients received CurQD in addition to Vedolizumab

Interventions

CurQD (Curcumin + QingDai combination)

Patients received CurQD in addition to Vedolizumab

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age >8 years
• Diagnosis of ulcerative colitis (self-reported)
• Completed Evinature clinical assessment between April 1, 2022, and cutoff date
• Vedolizumab treatment at baseline
• Active disease at entry (SCCAI ≥3 or PRO-2 ≥2 with RB ≥1)
• Initiated CurQD at entry

Exclusion Criteria

• Vedolizumab for indications other than UC
• Unclear medication status at baseline
• Not active disease when starting CurQD

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

Takeda Pharmaceuticals U.S.A., Inc.

UNKNOWN

Sponsor Role: collaborator

Evinature Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shomron Ben-Horin

Role: STUDY_DIRECTOR

Evinature Ltd.

Locations

Evinature

Binyamina, , Israel

Countries

Israel

References

Reinisch W, Bressler B, Curtis R, Parikh A, Yang H, Rosario M, Roseth A, Danese S, Feagan B, Sands BE, Ginsburg P, Dassopoulos T, Lewis J, Xu J, Wyant T. Fecal Calprotectin Responses Following Induction Therapy With Vedolizumab in Moderate to Severe Ulcerative Colitis: A Post Hoc Analysis of GEMINI 1. Inflamm Bowel Dis. 2019 Mar 14;25(4):803-810. doi: 10.1093/ibd/izy304.

Reference Type: RESULT

PMID: 30295811 (View on PubMed)

Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.

Reference Type: RESULT

PMID: 33359090 (View on PubMed)

Abreu MT, Rowbotham DS, Danese S, Sandborn WJ, Miao Y, Zhang H, Tikhonov I, Panaccione R, Hisamatsu T, Scherl EJ, Leong RW, Arasaradnam RP, Afif W, Peyrin-Biroulet L, Sands BE, Marano C. Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension. J Crohns Colitis. 2022 Aug 30;16(8):1222-1234. doi: 10.1093/ecco-jcc/jjac030.

Reference Type: RESULT

PMID: 35239968 (View on PubMed)

Walsh AJ, Ghosh A, Brain AO, Buchel O, Burger D, Thomas S, White L, Collins GS, Keshav S, Travis SP. Comparing disease activity indices in ulcerative colitis. J Crohns Colitis. 2014 Apr;8(4):318-25. doi: 10.1016/j.crohns.2013.09.010. Epub 2013 Oct 10.

Reference Type: RESULT

PMID: 24120021 (View on PubMed)

Ben-Horin S, Salomon N, Yanai H, Kopylov U. Letter: Change in Bowel Urgency in Active Ulcerative Colitis Patients Treated with Curcumin-QingDai (CurQD): A Post Hoc Analysis of a Randomized Placebo-Controlled Trial. J Crohns Colitis. 2025 Mar 5;19(3):jjae147. doi: 10.1093/ecco-jcc/jjae147. No abstract available.

Reference Type: RESULT

PMID: 39279191 (View on PubMed)

Ben-Horin S, Salomon N, Karampekos G, Viazis N, Lahat A, Ungar B, Eliakim R, Kuperstein R, Kriger-Sharabi O, Reiss-Mintz H, Yanai H, Dotan I, Zittan E, Maharshak N, Hirsch A, Weitman M, Mantzaris GJ, Kopylov U. Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2024 Feb;22(2):347-356.e6. doi: 10.1016/j.cgh.2023.05.023. Epub 2023 Jun 9.

Reference Type: RESULT

PMID: 37302449 (View on PubMed)

Chavannes M, Kandavel P, Danialifar T, Dillman J, Polk DB, Clinical, biochemical and intestinal ultrasonography response to curcumin-QIngDai (CurQD) combination in pediatric patients with inflammatory bowel disease: A case series, Inflam Bowel Dis 2024; 30, Suppl 1, Pages S18-S19, https://doi.org/10.1093/ibd/izae020.044

Reference Type: RESULT

Nachum NL, Salomon N, Yerushalmy-Feler A, Weintraub Y, Yogev D, Granot M, Haberman Y, Ben-Horin S, Weiss B. The efficacy of curcumin/Qing Dai combination in children with active ulcerative colitis: a multicenter retrospective cohort study. Front Pediatr. 2024 Sep 27;12:1342656. doi: 10.3389/fped.2024.1342656. eCollection 2024.

Reference Type: RESULT

PMID: 39403348 (View on PubMed)

Yanai H, Salomon N, Lahat A, Ungar B, Eliakim R, Kriger-Sharabi O, Reiss-Mintz H, Koslowsky B, Shitrit AB, Tamir-Degabli N, Dotan I, Zittan E, Maharshak N, Hirsch A, Ben-Horin S, Kopylov U. Real-world experience with Curcumin-QingDai combination for patients with active ulcerative colitis: A retrospective multicentre cohort study. Aliment Pharmacol Ther. 2023 Jul;58(2):175-181. doi: 10.1111/apt.17538. Epub 2023 May 8.

Reference Type: RESULT

PMID: 37157131 (View on PubMed)

Zittan E, Mahajna H, Salomon N. Attitudes Toward Integrative Medicine in Inflammatory Bowel Disease: A Survey Among Israeli Inflammatory Bowel Disease Experts. Inflamm Bowel Dis. 2023 Sep 1;29(9):e35-e36. doi: 10.1093/ibd/izad072. No abstract available.

Reference Type: RESULT

PMID: 37116868 (View on PubMed)

Ben-Horin S, Kopylov U, Salomon N. Curcumin-QingDai Combination as Treatment for Moderate-Severe Ulcerative Colitis. Case Rep Gastroenterol. 2022 Sep 20;16(3):563-568. doi: 10.1159/000526646. eCollection 2022 Sep-Dec.

Reference Type: RESULT

PMID: 36824698 (View on PubMed)

Other Identifiers

IIR-2024-200598

Identifier Type: -

Identifier Source: org_study_id