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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013534
Receipt No. R000015799
Scientific Title The elucidation of the action mechanism on the effectiveness of propagermanium for Crohn's disease
Date of disclosure of the study information 2014/03/28
Last modified on 2015/10/08

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Basic information
Public title The elucidation of the action mechanism on the effectiveness of propagermanium for Crohn's disease
Acronym The action mechanism of propagermanium for Crohn's disease (PROCD)
Scientific Title The elucidation of the action mechanism on the effectiveness of propagermanium for Crohn's disease
Scientific Title:Acronym The action mechanism of propagermanium for Crohn's disease (PROCD)
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate that the efficacy of the organic germanium compound propagermanium for Crohn's disease (CD) using the blood or the resection specimens (intestine) from patients with CD.
Basic objectives2 Others
Basic objectives -Others In a previous study, we found that propagermanium improved the pathological and intestinal lesion score in TNBS-induced colitis mice or rats, which shared pathological and immunological features with human CD. We speculated this effect caused by the inhibition of monocyte and/or macrophage migration in intestine by propagermanium, as reported before. Furthermore, we also obtained the data which suggests that propagermanium reduced the production of inflammatory cytokines which are reported as substantial cytokines for the etiology of CD.

We conducted to confirm whether the effects are represented in peripheral blood mononuclear cells (PBMC) or lamina propria mononuclear cells (LPMC), voluntary donated from the patients with CD.

This study was conducted in vitro setting and propagermanium was not administered to the patients with CD.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To confirm whether propagermanium inhibit the secretion of the inflammatory cytokines from LPS-stimulated human PBMC and LPMC.
Key secondary outcomes To explore the clinical and the therapeutic background of responders to propagermanium.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1.To collect approximately 20ml of peripheral blood from CD patients who are under medical examination and treatment in Hyogo College of Medicine.

2.To be provided approximately 30g of intestinal specimen from the patients with CD who undergoes intestinal resection in Hyogo College of Medicine.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who had a diagnosis of CD before participation to this study and who was able to provide written informed consent to be collected approximately 20ml of peripheral blood.

2.The CD patients who had necessity for intestinal resection because of exacerbation and who was able to provide written informed consent to provide approximately 30g of resected tissue in their surgery.
Key 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Nakamura
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease, Division of Internal Medicine
Zip code
Address 1-1,Mukogawa, Nishinomiya, Hyogo, 663-8501
TEL 0798-45-6663
Email shiro@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuko Nagase
Organization Hyogo College of Medicine
Division name Department of Inflammatory Bowel Disease, Division of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501
TEL 0798-45-6663
Homepage URL
Email kazuko@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Institute
Department

Funding Source
Organization Sanwa Kagaku Kenkyusho Co,, Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Sanwa Kagaku Kenkyusho Co,, Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 兵庫医科医大学病院(兵庫県)
Hyogo College of Medicine

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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. 

Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 20 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 02 Month 01 Day
Date analysis concluded
2014 Year 02 Month 28 Day

Other
Other related information 1.The title of this study was differ from the title we have applied previously to IRB in Hyogo College of Medicine:The effectiveness of propagermanium for Crohn's disease. Since this study was not a clinical trial, but an in vitro study to elucidate the action mechanism on the effectiveness of propagermanium for CD using peripheral blood and intestinal tissue donated from patients with CD. To clarify this feature, we decided the title of this study as: The elucidation of the action mechanism on the effectiveness of propagermanium for Crohn's disease.

2. At first, we have assumed colitic cancer (CC) as control disease for CD, but there was no patients with CC who could participate to this study. For this reason, all participants in this study was patients with CD.

Management information
Registered date
2014 Year 03 Month 27 Day
Last modified on
2015 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015799

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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