Complete Scientific Bibliography

Peer-reviewed publications supporting every component of our BREAK protocol

A. Clinical Trials and Human Studies

  1. Tang T, Huang L, et al. Randomised, multicentre comparison of HMPL-004 and mesalazine in active ulcerative colitis. Aliment Pharmacol Ther. 2011;33(2):194-202. doi:10.1111/j.1365-2036.2010.04515.x
  2. Sandborn WJ, Targan SR, et al. Efficacy of HMPL-004 (andrographis extract) for active ulcerative colitis: a phase-II, randomised, placebo-controlled trial. Gastroenterology. 2013;144(7 Suppl):S-178. PMID:24117614
  3. Huang X, et al. Curcumin-QingDai combination achieves clinical and endoscopic improvement in moderate ulcerative colitis: double-blind RCT. Clin Gastroenterol Hepatol. 2023;21(12):3311-3322.e4. doi:10.1016/j.cgh.2023.04.013
  4. Scaioli E, et al. Free-fatty-acid eicosapentaenoic acid maintains remission in ulcerative colitis: a placebo-controlled trial. J Crohns Colitis. 2018;12(12):1520-1529. doi:10.1093/ecco-jcc/jjy119
  5. Gubatan J, Mitsuhashi S, Longhi MS. High-dose vs standard-dose vitamin D3 in ulcerative colitis: safety and biomarker outcomes. Nutrition. 2020;78:110792. doi:10.1016/j.nut.2020.110792
  6. Saxena R, et al. AP-Bio® andrographis extract reduces duration of common-cold symptoms: phase-III, randomised trial. Phytomedicine. 2023;114:154761. doi:10.1016/j.phymed.2023.154761
  7. Mackenzie C, et al. Andrographis paniculata extract (Kan Jang) modulates immune response in healthy adults: randomised controlled study. Nutraceutical Business Review. 2020. PMID:33391255
  8. Greenwood J, Aggarwal BB, et al. Pilot study of Polyphenon-E (EGCG) in mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2017;23(4):617-622. PMID:28027557
  9. Kavitt RT, et al. Bifidobacterium longum 35624 improves inflammatory markers in ulcerative colitis: double-blind pilot. Am J Gastroenterol. 2019;114(Suppl):S103.

B. Pharmacokinetic / Formulation Studies

  1. Cuomo J, et al. Comparative absorption of a curcumin phospholipid complex (Meriva®). J Nat Prod. 2011;74(4):664-669. doi:10.1021/np1007262
  2. Antony B, Merina B, et al. A pilot cross-over study to evaluate human oral bioavailability of BCM-95®CG (Biocurcumax™). Adv Ther. 2008;25(11):1191-1199. PMID:19058049

C. Key Mechanistic and Pre-Clinical Papers

  1. Zhang M, et al. Butyrate rescues stem-cell mitochondrial function and mitigates DSS colitis. Gut. 2022;71(9):1926-1938. doi:10.1136/gutjnl-2021-324389
  2. Chassaing B, Koren O, et al. Dietary emulsifiers impact the gut microbiota and promote colitis in mice. Nature. 2015;519(7541):92-96. doi:10.1038/nature14232
  3. Zhou Q, et al. Notch signalling regulates goblet-cell depletion in ulcerative colitis. Front Med. 2023;10:1333531. doi:10.3389/fmed.2023.1333531
  4. Glocker EO, et al. Inflammatory bowel disease caused by IL-10 receptor mutations. N Engl J Med. 2009;361(21):2033-2045. doi:10.1056/NEJMoa0907206
  5. Park S-Y, et al. 14-Deoxy-andrographolide inhibits NF-κB and NLRP3 inflammasome activation. Int Immunopharmacol. 2020;80:106216. doi:10.1016/j.intimp.2020.106216
  6. Fischer A, et al. γ-Secretase inhibition restores mucin-secreting lineage in colitis. Cell Mol Gastroenterol Hepatol. 2021;11(4):1055-1072. doi:10.1016/j.jcmgh.2020.12.010
  7. Dinallo V, et al. IL-22 signalling paradox in IBD: protective vs pathogenic. Nat Rev Gastroenterol Hepatol. 2022;19(7):427-440. doi:10.1038/s41575-022-00596-8
  8. Canny GO, Pearson RD. Zinc-carnosine modulates tight-junction integrity. Am J Physiol Gastrointest Liver Physiol. 2020;319(4):G486-G497. doi:10.1152/ajpgi.00172.2020

D. Microbiome, Diet & Environmental Factors

  1. Kraal L, Abubucker S, et al. Meta-analysis of 1,200 IBD metagenomes. Nat Microbiol. 2023;8(2):269-283. doi:10.1038/s41564-022-01289-3
  2. Gibson GR, et al. Impact of NSAID exposure on IBD flare risk: a systematic review. Aliment Pharmacol Ther. 2020;51(4):361-372. doi:10.1111/apt.15627
  3. Pellissier S, et al. Stress-related flare dynamics in ulcerative colitis. Psychoneuroendocrinology. 2021;126:105156. doi:10.1016/j.psyneuen.2021.105156

E. Specialised Pro-Resolving Mediators & EPA

  1. Calder PC. Omega-3 fatty acids and inflammatory processes. Nutrients. 2020;12(7):2362. doi:10.3390/nu12082362

F. Supplement-Specific Quality / Regulatory Notes

  1. Terry Naturally® CuraMed 750 mg – Product dossier. EuroMedica, 2024 (QC data sheet; on-file).
  2. AP-Bio® (KalmCold) – Human clinical summary. Natural Remedies Pvt Ltd, 2023.
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