drugset / Trial / NCT03869905
Aquamin® as an Adjuvant Intervention for Ulcerative Colitis
RandomizedParallel-groupTriple-blindSupportive care
Summary
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.
Timeline
- Start
- 2019-08-08
- Primary completion
- 2027-12
- Completion
- 2027-12
Publications
- Background Aslam MN, McClintock SD, Attili D, Pandya S, Rehman H, Nadeem DM, Jawad-Makki MAH, Rizvi AH, Berner MM, Dame MK, Turgeon DK, Varani J. Ulcerative Colitis-Derived Colonoid Culture: A Multi-Mineral-Approach to Improve Barrier Protein Expression. Front Cell Dev Biol. 2020 Nov 23;8:577221. doi: 10.3389/fcell.2020.577221. eCollection 2020.
- Background Attili D, McClintock SD, Rizvi AH, Pandya S, Rehman H, Nadeem DM, Richter A, Thomas D, Dame MK, Turgeon DK, Varani J, Aslam MN. Calcium-induced differentiation in normal human colonoid cultures: Cell-cell / cell-matrix adhesion, barrier formation and tissue integrity. PLoS One. 2019 Apr 17;14(4):e0215122. doi: 10.1371/journal.pone.0215122. eCollection 2019.
- Background McClintock SD, Attili D, Dame MK, Richter A, Silvestri SS, Berner MM, Bohm MS, Karpoff K, McCarthy CL, Spence JR, Varani J, Aslam MN. Differentiation of human colon tissue in culture: Effects of calcium on trans-epithelial electrical resistance and tissue cohesive properties. PLoS One. 2020 Mar 5;15(3):e0222058. doi: 10.1371/journal.pone.0222058. eCollection 2020.
- Background Aslam MN, Bassis CM, Bergin IL, Knuver K, Zick SM, Sen A, Turgeon DK, Varani J. A Calcium-Rich Multimineral Intervention to Modulate Colonic Microbial Communities and Metabolomic Profiles in Humans: Results from a 90-Day Trial. Cancer Prev Res (Phila). 2020 Jan;13(1):101-116. doi: 10.1158/1940-6207.CAPR-19-0325. Epub 2019 Nov 26.
- Background Aslam MN, McClintock SD, Jawad-Makki MAH, Knuver K, Ahmad HM, Basrur V, Bergin IL, Zick SM, Sen A, Turgeon DK, Varani J. A Multi-Mineral Intervention to Modulate Colonic Mucosal Protein Profile: Results from a 90-Day Trial in Human Subjects. Nutrients. 2021 Mar 14;13(3):939. doi: 10.3390/nu13030939.
- Background Varani J, McClintock SD, Aslam MN. Organoid culture to study epithelial cell differentiation and barrier formation in the colon: bridging the gap between monolayer cell culture and human subject research. In Vitro Cell Dev Biol Anim. 2021 Feb;57(2):174-190. doi: 10.1007/s11626-020-00534-6. Epub 2021 Jan 5.
- Background Varani J, McClintock SD, Aslam MN. Cell-Matrix Interactions Contribute to Barrier Function in Human Colon Organoids. Front Med (Lausanne). 2022 Mar 10;9:838975. doi: 10.3389/fmed.2022.838975. eCollection 2022.
- Aslam MN, Turgeon DK, Appelman HD, Stidham R, McClintock S, Allen R, Moraga G, Harber I, Jencks KJ, McNeely MM, Sen A, Jepsen KJ, Varani J. A multi-mineral intervention to improve disease-related and mechanistic biomarkers in ulcerative colitis patients: Results from a randomized trial. PLoS One. 2025 Dec 8;20(12):e0337408. doi: 10.1371/journal.pone.0337408. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aquamin | Other / unclassified | 800 mg | — |