UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008858
Receipt number R000010400
Scientific Title Clinical study to investigate the therapeutic effect of 1-kestose on atopic dermatitis
Date of disclosure of the study information 2012/09/05
Last modified on 2017/03/13 16:12:28

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Basic information

Public title

Clinical study to investigate the
therapeutic effect of 1-kestose on atopic
dermatitis

Acronym

Effect of 1-kestose on atopic dermatitis

Scientific Title

Clinical study to investigate the
therapeutic effect of 1-kestose on atopic
dermatitis

Scientific Title:Acronym

Effect of 1-kestose on atopic dermatitis

Region

Japan


Condition

Condition

Atopic dermatitis

Classification by specialty

Clinical immunology Pediatrics Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the clinical effect of 1-
kestose, a fructo-oligosaccharide, on
atopic dermatitis, based on a multicenter
randomized controlled trial.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Severity score based on the Severity
Scoring of Atopic Dermatitis (SCORAD) 6
weeks after the begining of the
administration

Key secondary outcomes

1. SCORAD scores 12 weeks after the
begining of the administration and 6
weeks after the end of the administration
2. Bifidobacterial count and strain
structure, staphylococcus aureus count
3. Permeability test of the intestinal
mucosa (lactulose/mannitol load test)
4. Bloot tests (white blood cell count,
eosinophil count, immunoglobulin E,
ImmunoCAP-ovalbumin/milk/mites,
Thymus and Activation-Regulated
Chemokine)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intervention (1-kestose) group

Period: 12 weeks
Dose: 1g/day (age < 1 year), 2g/day
(1-3 years), or 3g/day (4-6 years). A
half dose per time, twice per day.

Interventions/Control_2

Control (maltose) group

Period and dose: same as the
intervention group.

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

6 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients with atopic dermatitis
2. "Severe" or milder disease according to the "Guidelines for the Treatment of
Atopic Dermatitis 2005" by the Japan Health Labour Sciences Research Group
3. Non-user of external corticosteroids or users of external corticosteroids that are classified as "strong" or weaker.

Key exclusion criteria

1. Users of external corticosteroids that
are classified as "very strong" or "stronger"
2. Patients who regularly use
probiotics/prebiotics other than 1-kestose for therapeutic purposes
3. Patients who regularly use antibiotics
4. Patients who are judged as ineligible
by doctor in charge

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiro Koga

Organization

Tokai University School of Medicine

Division name

Laboratory for infectious disease

Zip code


Address

Isehara, Kanagawa prefecture, 259-1193 Japan

TEL

0463-93-1121

Email

YASUHIRO@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuhiro Koga

Organization

Tokai University School of Medicine

Division name

Laboratory for infectious disease

Zip code


Address

Isehara, Kanagawa prefecture, 259-1193 Japan

TEL

0463-93-1121

Homepage URL


Email

YASUHIRO@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Tokai University School of Medicine

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

国立病院機構福岡病院小児科
国立病院機構福岡東医療センター小児科
福岡大学病院小児科


Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 05 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


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

2012 Year 06 Month 04 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 10 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry

2015 Year 08 Month 31 Day

Date trial data considered complete

2015 Year 08 Month 31 Day

Date analysis concluded

2016 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 09 Month 05 Day

Last modified on

2017 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name