UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033350
Receipt number R000038020
Scientific Title Analysis of human gut microbiome in severe food allergic patients
Date of disclosure of the study information 2018/07/10
Last modified on 2023/07/14 16:20:53

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Basic information

Public title

Analysis of human gut microbiome in severe food allergic patients

Acronym

Analysis of human gut microbiome in severe food allergic patients

Scientific Title

Analysis of human gut microbiome in severe food allergic patients

Scientific Title:Acronym

Analysis of human gut microbiome in severe food allergic patients

Region

Japan


Condition

Condition

Food allergy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze human gut microbiome in severe food allergic patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intestinal microbiota

Key secondary outcomes

Short chain fatty acids (Acetic acid, butyric acid, propionic acid, valeric acid) in serum


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

5 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

GroupA:
Patients who developed objective symptoms during an oral food challenge to 1/32 of heated whole egg, 3 ml of heated cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of peanut or 0.5g of nut.
Patients who desired to receive oral immunotherapy.
GroupB:
Patients who were 5 years of age or older.
Patients who regularly visit our hospital for food allergy.
Patients who did not desire to receive oral immunotherapy.
GroupC:
Patients who were 5 years of age or older.
Patients who regularly visit our hospital for the exception of food allergy.
Patients who did not desire to receive oral immunotherapy.

Key exclusion criteria

Decision of ineligibility by a physician

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Noriyuki
Middle name
Last name Yanagida

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Pediatrics

Zip code

252-0392

Address

18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392

TEL

042-742-8311

Email

ssakura8010@foodallergy.jp


Public contact

Name of contact person

1st name Ken-ichi
Middle name
Last name Nagakura

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of pediatrics

Zip code

252-0392

Address

18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392

TEL

042-742-8311

Homepage URL


Email

k.nagakura@foodallergy.jp


Sponsor or person

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Sagamihara National Hospital

Address

18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392

Tel

042-742-8311

Email

222-rinri@mail.hosp.go.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

2018 Year 07 Month 10 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

No longer recruiting

Date of protocol fixation

2018 Year 07 Month 05 Day

Date of IRB

2018 Year 06 Month 15 Day

Anticipated trial start date

2018 Year 07 Month 17 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Intestinal microbiota
Short chain fatty acids (Acetic acid, butyric acid, propionic acid, valeric acid) in serum


Management information

Registered date

2018 Year 07 Month 10 Day

Last modified on

2023 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038020


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name