UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062875 |
|---|---|
| Receipt number | R000071988 |
| Scientific Title | Maternal Immunosuppressive Therapy and Neonatal Transient Immunodeficiency Study: A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/16 09:40:24 |
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Basic information
Public title
Maternal Immunosuppressive Therapy and Neonatal Transient Immunodeficiency Study
Acronym
MINT study
Scientific Title
Maternal Immunosuppressive Therapy and Neonatal Transient Immunodeficiency Study: A Multicenter Prospective Observational Study
Scientific Title:Acronym
MINT study
Region
| Japan |
Condition
Condition
pregnant women
Classification by specialty
| Gastroenterology | Clinical immunology | Obstetrics and Gynecology |
| Pediatrics | Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to elucidate the immunological characteristics from birth through the neonatal period in infants born to mothers undergoing immunosuppressive therapy, as well as the incidence of complications suspected to be associated with postnatal immunosuppression. The study will focus on an evaluation of TREC and KREC screening results and the clinical course from birth to one year of age. For infants from whom umbilical cord blood was obtained, detailed immunocellular profiling using FACS will be performed to examine the correlation with screening results and to identify immunological characteristics not detected by screening. The findings will be utilised to inform the risk assessment and clinical management of pregnant women requiring immunosuppressive therapy and their newborns.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints for the drug-exposed group and the disease-matched control group are the frequency of abnormal TREC and KREC screening results in the neonatal period, and the incidence of complications suspected to be associated with immunosuppression from birth to one year of age.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study will include pregnant women aged 18 years or over receiving antenatal care at participating facilities, as well as the infants born from those pregnancies and the infants biological fathers. Pregnant women will be enrolled in the drug-exposed group, the disease control group and the healthy pregnancy control group, whilst participation by the infants' biological fathers is voluntary.
Key exclusion criteria
Where it is difficult to ensure the subject's understanding of the study and confirmation of their consent, and where appropriate alternative consent procedures cannot be applied.
Where the attending physician judges that it is inappropriate to carry out the study procedures due to circumstances requiring priority to be given to the safety of the mother and child or to clinical care.
Where the treatment or pregnancy information necessary to determine the study group cannot be obtained.
In any other circumstances where the attending physician considers it inappropriate.
Target sample size
9999
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Graduate School of Medicine, Tohoku University
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku Sendai, Miyagi
TEL
022-717-7171
mint@ibd.ai
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Graduate School of Medicine, Tohoku University
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku Sendai, Miyagi
TEL
022-717-7171
Homepage URL
mint@ibd.ai
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2026 | Year | 11 | 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 | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071988
