UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028203
Receipt number R000032125
Scientific Title Usefulness of kestose with Inflammatory Bowel Disease
Date of disclosure of the study information 2017/07/12
Last modified on 2022/04/27 20:48:48

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Basic information

Public title

Usefulness of kestose with Inflammatory Bowel Disease

Acronym

Treatment with kestose for Inflammatory Bowel Disease

Scientific Title

Usefulness of kestose with Inflammatory Bowel Disease

Scientific Title:Acronym

Treatment with kestose for Inflammatory Bowel Disease

Region

Japan


Condition

Condition

Inflammatory Bowel Disease

Classification by specialty

Gastroenterology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of kestose in the patients with Inflammatory Bowel Disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement of clinical condition in patients with Inflammatory Bowel Disease

Key secondary outcomes

1.Changes of short-chain fatty acid (Butyric acid,Acetic acid,Propionic acid etc.)
2.changes of endoscopic score
3.changes of concentration of carprotectin in feces
4.Changes of pathologic and metabolic marker (T.Cho, LDL-Cho, HDL-Cho, TG, FFA, ferritin,HbA1c,CRP,TP,ALB etc.)
5.Correlation of gut microbiota and therapeutic effect
6.Changes of body weight and BMI
7.Metabolome and protein analysis of metabolite in feces
8.Changes of bile acid
9.Correlation between expiratory noble gases, gut microbiota and NAFLD/NASH
10.Correlation between usefulness of kestose and disease prognosis in the patients with Inflammatory Bowel Disease


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

kestose

Interventions/Control_2

placebo

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

Patients diagnosed as Inflammatory Bowel Disease(ulcerative colitis,crohn disease)

Key exclusion criteria

1.Women with pregnancy or possible pregnancy
2.Patients with severe renal failure and heart failure
3.Patient who is considered to be inappropriate for entry into the trial by the investigator
4.Medical doctors decided the patients are inappropriate.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Hirooka

Organization

Nagoya University Hospital

Division name

Department of Endoscopy

Zip code


Address

65 tsurumai-cho, Showa-ku, Nagoya

TEL

+81-52-744-2602

Email

hirooka@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keisaku yamada

Organization

Nagoya University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

65 tsurumai-cho, Showa-ku, Nagoya

TEL

+81-52-744-2602

Homepage URL


Email

kei-yama@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

B Food Science Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 12 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

Completed

Date of protocol fixation

2017 Year 07 Month 08 Day

Date of IRB

2017 Year 09 Month 07 Day

Anticipated trial start date

2018 Year 04 Month 06 Day

Last follow-up date

2021 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 12 Day

Last modified on

2022 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032125


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name