UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038461
Receipt number 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 11:00:04

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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

Japan


Condition

Condition

Inflammatory bowel disease (IBD)

Classification by specialty

Gastroenterology

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

Food

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

20 years-old <=

Age-upper limit

70 years-old >=

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

1st name Shunji
Middle name
Last name Ishihara

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

Email

si360405@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Shunji
Middle name
Last name Ishihara

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


Email

si360405@med.shimane-u.ac.jp


Sponsor or person

Institute

Shimane University Faculty of Medicine
Internal Medicine II

Institute

Department

Personal name



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

Email

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

2019 Year 11 Month 01 Day


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.

Results date posted

2020 Year 05 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

IBD patients Healthy control

Participant flow

outpatients clinic, laboratory room

Adverse events

bo adverse events

Outcome measures

safety, blood concentration level of chitosan

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Suspended

Date of protocol fixation

2018 Year 05 Month 25 Day

Date of IRB

2018 Year 05 Month 25 Day

Anticipated trial start date

2018 Year 08 Month 05 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 01 Day

Last modified on

2020 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043830


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name