UMIN-CTR Clinical Trial
| Recruitment status | Suspended |
| Unique ID issued by UMIN | UMIN000038461 |
| Receipt No. | R000043830 |
| Scientific Title | Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phas I, II study) |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/05/02 (Ver. 2) |
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| Basic information | ||
| Public title | Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phase I, II study) | |
| Acronym | A novel evaluation method for intestinal permeability | |
| Scientific Title | Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phas I, II study) | |
| Scientific Title:Acronym | A novel evaluation method for intestinal permeability | |
| Region |
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| Condition | ||
| Condition | Inflammatory bowel disease (IBD)
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| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | The aim of this study is to investigate intestinal permeability for IBD patients and clarify its clinical importance. |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Determination of chitosan dose for administarion (Phase I: after 1 and 4 hours) and evaluation of symptoms and blood examination (Phase I: by 1 month). Correlation between blood concentration level of chitosan and disease activity of IBD (Phase II. at administration). |
| Key secondary outcomes | |
| 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 | Diagnosis | |
| Type of intervention |
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| Interventions/Control_1 | chitosan | |
| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Patients with Crohn's disease and ulcerative colitis | |||
| Key exclusion criteria | Patients who physicians judge as inappropriate | |||
| Target sample size | 132 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Shimane University Faculty of Medicine | ||||||
| Division name | Internal Medicine II | ||||||
| Zip code | 693-8501 | ||||||
| Address | Enya-cho 89-1, Izumo, ShImane | ||||||
| TEL | 0853-20-2190 | ||||||
| si360405@med.shimane-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Shimane University Faculty of Medicine | ||||||
| Division name | Internal Medicine II | ||||||
| Zip code | 693-8501 | ||||||
| Address | Enya-cho 89-1, Izumo, ShImane | ||||||
| TEL | 0853-20-2190 | ||||||
| Homepage URL | |||||||
| si360405@med.shimane-u.ac.jp | |||||||
| Sponsor | |
| Institute | Shimane University Faculty of Medicine
Internal Medicine II |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Shimane University Faculty of Medicine
Internal Medicine II |
| Organization | |
| Division | |
| Category of Funding Organization | Other |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Medical Ethics Committee of Shimane University |
| Address | Enya-cho 89-1, Izumo, ShImane |
| Tel | 0853-20-2515 |
| kenyu@med.shimane-u.ac.jp | |
| 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 | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | N/A |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | N/A | ||||||
| Number of participants that the trial has enrolled | 22 | ||||||
| Results | Seventeen patients and 5 controls were enrolled. However, blood concentration levels of chitosan were less than cut-off or very low. We re-consider the study protocol. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | IBD patients　Healthy control |
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| Participant flow | outpatients clinic, laboratory room |
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| Adverse events | bo adverse events |
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| Outcome measures | safety, blood concentration level of chitosan |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Suspended | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043830 |
