UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043247
Receipt number R000049337
Scientific Title Measurement of intestinal permeability using lactulose and mannitol test
Date of disclosure of the study information 2021/02/07
Last modified on 2024/03/15 12:46:26

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Basic information

Public title

Measurement of intestinal permeability using lactulose and mannitol test

Acronym

Measurement of intestinal permeability using lactulose and mannitol test

Scientific Title

Measurement of intestinal permeability using lactulose and mannitol test

Scientific Title:Acronym

Measurement of intestinal permeability using lactulose and mannitol test

Region

Japan


Condition

Condition

gastrointestinal disease

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of intestinal barrier function in gastrointestinal diseases

Basic objectives2

Others

Basic objectives -Others

Identification of the frequency and severity of intestinal barrier dysfunction and its association with prognosis

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To investigate the frequency and severity of intestinal barrier dysfunction and its association with prognosis in each disease

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

Prevention

Type of intervention

Food

Interventions/Control_1

Sugar tolerance test: After a single dose of sugar solution (lactulose 10g, mannitol 5g), collect urine after 6hours.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. 20<= 80> year-old females and males
2. Subject must read and sign the informed consent form

Key exclusion criteria

1. Presence of galactosemia
2. Presence of an allergy to food containing sugar alcohol
3.Diabetic patients with poor glycemic control
4.Patients who do not consent to participate in this study
5. Determined ineligible by the principal investigator or sub-investigator

Target sample size

750


Research contact person

Name of lead principal investigator

1st name Mikihiro
Middle name
Last name Fujiya

Organization

Asahikawa Medical University

Division name

Gastroenterology and Endoscopy, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology

Zip code

078-8510

Address

2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido

TEL

0166-68-2462

Email

fjym@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Aki
Middle name
Last name Sakatani

Organization

Asahikawa Medical University

Division name

Gastroenterological Pathophysiology

Zip code

078-8510

Address

2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido

TEL

0166-68-2462

Homepage URL


Email

sakatani@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University
Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology

Institute

Department

Personal name



Funding Source

Organization

Asahikawa Medical University
Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahikawa Medical University Ethics Committee

Address

2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido

Tel

0166-68-2462

Email

sho-kenkyu@jimu.asahikawa-med.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

旭川医科大学病院


Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 07 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Enrolling by invitation

Date of protocol fixation

2021 Year 02 Month 01 Day

Date of IRB

2021 Year 01 Month 25 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2025 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

2021 Year 02 Month 04 Day

Last modified on

2024 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name