The elucidation of the action mechanism on the effectiveness of propagermanium for Crohn's disease

Not Applicable

• Conditions: Crohn' s disease

• Registration Number: JPRN-UMIN000013534
• Lead Sponsor: Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine

Brief Summary

Experiment 1: The anti-inflammatory effect of PGe in PBMCs of CD patients. We were provided with 28 PBMC samples from 26 patients with CD. PBMC samples were incubated with PGe at 2 μg/mL for one hour before being stimulated with LPS at 15pg/mL for another 24 hour. The supernatants were used as a source for the cytokines. TNF-α and IL-6 levels were assayed using enzyme immunoassay kits. Overall, PGe significantly reduced the production of TNF-α and IL-6 compared with samples without PGe as control test. Experiment 2: The anti-inflammatory effect of PGe in LPMCs of CD patients. We were provided with five intestinal specimens. LPMCs were isolated from the intestinal specimens by using a modified technique originally described by Kamada, et al. (Reference). Then we isolated CD14+CD33+ macrophages from LPMCs which were reported to produce pro-inflammatory cytokines including IL-23, TNF-α and IL-6 and have a key role in the pathogenesis of CD. However, we could not isolate enough CD14+CD33+ macrophages for the following experiment to show PGe's effects. In view of these limitations, we decided to discontinue experiment 2 using CD14+CD33+ macrophages isolated from LPMCs. In conclusion, PGe reduced the production of inflammatory cytokines produced by CD patient's PBMCs. Accordingly, PGe seems to be a potential drug for IBD patients, especially, in the HBV carrier IBD patients or the patients who are intolerant to biological therapy. The results of this study was presented in the poster session on The 101th general meeting of Japanese society of Gastroenterology 2015 on April 9th, 2015 held at Sendai, Miyagi, Japan. Reference Kamada N, Hisamatsu T, Okamoto S, et al. J Clin Invest. 2008 Jun;118(6):2269-80.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-12-20
• Study Start: 2014-03-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who could not provide written informed consent to be provide peripheral blood or intestinal tissue. 2.Patient who was administrated high dose of corticosteroids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified