UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058962 |
|---|---|
| Receipt number | R000067428 |
| Scientific Title | Study on the Impact of GLP-2 Analogue Therapy on the Gut Microbiota in Children with Short Bowel Syndrome |
| Date of disclosure of the study information | 2025/09/10 |
| Last modified on | 2025/09/02 11:59:49 |
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Basic information
Public title
Study on the Effects of Teduglutide on the Gut Microbiota of Pediatric Patients with Short Bowel Syndrome
Acronym
Teduglutide and Gut Microbiota
Scientific Title
Study on the Impact of GLP-2 Analogue Therapy on the Gut Microbiota in Children with Short Bowel Syndrome
Scientific Title:Acronym
GLP-2 Analogues and Gut Microbiota in Pediatric Short Bowel Syndrome
Region
| Japan |
Condition
Condition
Short Bowel Syndrome
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the gut microbiota composition in pediatric short bowel syndrome (SBS) patients treated with teduglutide and to investigate the presence of treatment-specific microbial alterations through comparison with published datasets.
Basic objectives2
Others
Basic objectives -Others
This study analyzes fecal samples from pediatric short bowel syndrome (SBS) patients receiving teduglutide at the University of Tsukuba Hospital and compares the gut microbiota profiles with internationally available data from SBS patients not receiving teduglutide. By utilizing published datasets in place of a conventional control group, the study establishes a feasible and ethical framework for comparative analysis. The findings are expected to provide ecological evidence supporting the clinical efficacy of teduglutide, contribute to understanding its mechanism of action and potential monitoring biomarkers, and offer insights that may guide future personalized medicine and intestinal rehabilitation strategies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Characteristics of gut microbiota diversity indices in pediatric SBS patients receiving teduglutide
Dominant bacterial taxa in the gut microbiota of pediatric SBS patients receiving teduglutide
Key secondary outcomes
Correlation between gut microbiota and clinical parameters in pediatric SBS patients receiving teduglutide
Functional prediction of the gut microbiota in pediatric SBS patients receiving teduglutide
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
Children with short bowel syndrome (SBS) aged 15 years or younger receiving teduglutide
Key exclusion criteria
Patients who have had an infectious or inflammatory disease within the past 3 months
Patients who have been receiving teduglutide for less than 1 month since initiation
Patients deemed ineligible by the principal investigator for any other reason
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Masumoto |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Pediatric Surgery
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298533516
kmasu@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Aiyoshi |
Organization
University of Tsukuba Hospital
Division name
Department of Pediatric Surgery
Zip code
3058576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
0298533516
Homepage URL
t.aiyoshi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of the University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
0298533900
t-credo.adm@un.tsukuba.ac.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
| 2025 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study collects fecal samples and clinical data from pediatric short bowel syndrome (SBS) patients receiving teduglutide to analyze their gut microbiota. Bacterial DNA will be extracted and 16S rRNA gene sequencing (V3V4 region) performed, with data analyzed using QIIME2 and compared to publicly available datasets from nontreated patients. Statistical analyses in R, including MaAsLin2 and redundancy analysis, will assess associations with clinical parameters, while PICRUSt2 will be used to predict functional pathways and explore the impact of teduglutide on the gut microbiota.
Management information
Registered date
| 2025 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067428
