UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060888 |
|---|---|
| Receipt number | R000069569 |
| Scientific Title | Estimation of the Prevalence of Celiac Disease Among Japanese Pediatric Patients Diagnosed With Irritable Bowel Syndrome or Functional Dyspepsia: A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/10 15:43:48 |
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Basic information
Public title
Estimation of the Prevalence of Celiac Disease Among Japanese Pediatric Patients Diagnosed With Irritable Bowel Syndrome or Functional Dyspepsia: A Multicenter Prospective Observational Study
Acronym
Estimation of the Prevalence of Celiac Disease Among Japanese Pediatric Patients Diagnosed With Irritable Bowel Syndrome or Functional Dyspepsia
Scientific Title
Estimation of the Prevalence of Celiac Disease Among Japanese Pediatric Patients Diagnosed With Irritable Bowel Syndrome or Functional Dyspepsia: A Multicenter Prospective Observational Study
Scientific Title:Acronym
Estimation of the Prevalence of Celiac Disease Among Japanese Pediatric Patients Diagnosed With Irritable Bowel Syndrome or Functional Dyspepsia
Region
| Japan |
Condition
Condition
Irritable Bowel Syndrome and Functional Dyspepsia
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The positive rate of serum anti-tissue transglutaminase IgA antibody (tTG-IgA) among pediatric patients diagnosed with IBS or FD according to Rome IV criteria.
Basic objectives2
Others
Basic objectives -Others
To estimate the prevalence of confirmed celiac disease among participants with positive tTG-IgA results.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The positive rate of serum anti-tissue transglutaminase IgA antibody (tTG-IgA) among pediatric patients diagnosed with IBS or FD according to Rome IV criteria.
Key secondary outcomes
The prevalence of confirmed Celiac disease among tTG-IgA positive patients.
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese patients under 15-year-old age diagnosed as IBS according to Rome 4 criteria.
Japanese patients under 15-year-old age diagnosed as FD according to Rome 4 criteria.
Key exclusion criteria
Patients that physicians have deemed inappropriate due to their complications or treatment history.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Takaki |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of Pediatric Gastroenterology and Hepatology
Zip code
861-8520
Address
Nagamine-minami 2-1-1, Higashi-ku, Kumamoto City, Kumamoto, Japan
TEL
0963842111
tturmso@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Takaki |
Organization
Japanese Red Cross Kumamoto Hospital
Division name
Department of Pediatric Gastroenterology and Hepatology
Zip code
861-8520
Address
Nagamine-minami 2-1-1, Higashi-ku, Kumamoto City, Kumamoto, Japan
TEL
0963842111
Homepage URL
tturmso@yahoo.co.jp
Sponsor or person
Institute
Japanese Red Cross Kumamoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Kumamoto Hospital
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
Japanese Red Cross Kumamoto Hospital
Address
Nagamine-minami 2-1-1, Higashi-ku, Kumamoto City, Kumamoto, Japan
Tel
0963842111
tturmso@yahoo.co.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
熊本赤十字病院（熊本県）、信州大学病院（長野県）、埼玉県立小児医療センター（埼玉県）、東京都立小児総合医療センター（東京都）、大阪母子医療センター（大阪府）、久留米大学病院（福岡県）、佐賀大学医学部附属病院（佐賀県）、広島大学病院（広島県）、金沢大学医学部附属病院（石川県）、広島市立舟入市民病院（広島県）、杏林大学医学部付属杉並病院（東京都）、東京慈恵会医科大学葛飾医療センター（東京都）、富士市立中央病院（静岡県）、東京医科大学病院（東京都）、帝京大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study conducted in Japan. Pediatric patients younger than 15 years who are diagnosed with irritable bowel syndrome (IBS) or functional dyspepsia (FD) according to the Rome IV criteria will be consecutively enrolled at participating institutions. After obtaining informed consent from guardians and assent from children when appropriate, approximately 2 mL of additional blood will be collected at the time of routine clinical blood sampling.
Serum anti-tissue transglutaminase IgA antibody (tTG-IgA) will be measured at a central laboratory. Blood samples collected at participating institutions will be anonymized and transported to the coordinating center before analysis. Clinical information including demographic data, clinical symptoms, laboratory findings, and endoscopic findings (when performed) will be collected using standardized data sheets.
Participants with positive tTG-IgA results who wish to pursue further evaluation may undergo HLA-DQ typing and duodenal biopsy under routine clinical practice for diagnostic confirmation. The study aims to estimate the prevalence of celiac disease among Japanese pediatric patients presenting with functional gastrointestinal disorders.
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069569
