UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061766 |
|---|---|
| Receipt number | R000070204 |
| Scientific Title | Pediatric Enteral Assessment of Real-world Long-term outcomes with Teduglutide for Short Bowel Syndrome in Japan |
| Date of disclosure of the study information | 2026/06/02 |
| Last modified on | 2026/06/02 14:28:16 |
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Basic information
Public title
Pediatric Enteral Assessment of Real-world Long-term outcomes with Teduglutide for Short Bowel Syndrome in Japan
Acronym
Pediatric Enteral Assessment of Real-world Long-term outcomes with Teduglutide for Short Bowel Syndrome in Japan: PEARL-J
Scientific Title
Pediatric Enteral Assessment of Real-world Long-term outcomes with Teduglutide for Short Bowel Syndrome in Japan
Scientific Title:Acronym
Pediatric Enteral Assessment of Real-world Long-term outcomes with Teduglutide for Short Bowel Syndrome in Japan: PEARL-J
Region
| Japan |
Condition
Condition
Short Bowel Syndrome
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to retrospectively collect and analyze actual clinical experience with teduglutide in patients with SBS weighing less than 10 kg in Japan to clarify their background characteristics and clinical course. Specifically, the objective is to investigate patient background characteristics; growth and developmental status; changes in PS volume and the effect of these changes on long-term (beyond one year) prognosis; changes in nutritional status; effects on liver function and PS catheter management; caregiver burden at home; and improvements in QoL.
Basic objectives2
Others
Basic objectives -Others
- Growth-related parameter (weight-for-age Z-score) from the start date of teduglutide treatment through Week 52
- Background characteristics of pediatric patients with SBS weighing less than 10 kg who received teduglutide
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
- Growth-related parameter (weight-for-age Z-score) from the start date of teduglutide treatment through Week 52
- Background characteristics of pediatric patients with SBS weighing less than 10 kg who received teduglutide
Key secondary outcomes
- Growth-related parameters (height, weight, and head circumference-for-age Z-scores) after teduglutide treatment
- PS volume and frequency after teduglutide treatment
- Evaluation of PS volume reduction after teduglutide treatment
- Parameters related to weaning from PS
- Parameters related to changes in intestinal absorption capacity after teduglutide treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Legal guardian has signed and dated a written informed consent form
- Corrected gestational age was 4 months or older at the start of teduglutide treatment
- Body weight was less than 10 kg on the start date of teduglutide treatment
- Diagnosis of SBS with intestinal failure, defined as dependence on PS to provide at least 30% of fluid or caloric requirements
- The volumes of PS were stable following the intestinal adaptation period or further reduction was considered unlikely at the start of teduglutide treatment
- Received at least one dose of teduglutide
- Treatment with teduglutide was consistent with the approved indication
Key exclusion criteria
- Legal guardian did not provide written informed consent
- Use of teduglutide was determined to be off-label based on product information, as judged by the study doctor
- The patient was known to have died at the time informed consent was obtained
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medial Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
03-3278-2111
miwa.izutsu@takeda.com
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Suzuki |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
03-3278-2111
Homepage URL
mayu.suzuki@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
Non-Profit Organization MINS Research Ethics Committee (Non-Profit Organization MINS REC)
Address
5-20-9-401 Mita, Minato-ku, Tokyo 108-0073, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
東北大学病院（宮城県）、宮城県立こども病院（宮城県）、筑波大学附属病院（茨城県）、群馬県立小児医療センター（群馬県）、千葉大学医学部附属病院（千葉県）、順天堂大学医学部附属順天堂医院（東京都）、慶應義塾大学病院（東京都）、地方独立行政法人東京都立病院機構 都立小児総合医療センター（東京都）、日本赤十字社医療センター（東京都）、東海大学医学部付属病院（神奈川県）、地方独立行政法人神奈川県立病院機構 神奈川県立こども医療センター（神奈川県）、新潟大学医歯学総合病院（新潟県）、地方独立行政法人静岡県立病院機構 静岡県立こども病院（静岡県）、社会福祉法人聖隷福祉事業団 総合病院 聖隷浜松病院（静岡県）、名古屋市立大学医学部附属西部医療センター（愛知県）、あいち小児保健医療総合センター（愛知県）、京都大学医学部附属病院（京都府）、京都府立医科大学附属病院（京都府）、地方独立行政法人大阪府立病院機構 大阪母子医療センター（大阪府）、社会医療法人愛仁会 高槻病院（大阪府）、九州大学病院（福岡県）、久留米大学病院（福岡県）、福岡市立こども病院（福岡県）、独立行政法人国立病院機構 長崎医療センター（長崎県）、鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 02 | 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
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a clinical study targeting pediatric short bowel syndrome (SBS) patients in Japan who weigh less than 10 kg and have received teduglutide. It consists of an observational study aimed at understanding patient background, growth and development, and clinical course at the time of teduglutide administration, as well as a questionnaire survey designed to assess caregiver burden for pediatric SBS patients.
Management information
Registered date
| 2026 | Year | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070204
