UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054016 |
|---|---|
| Receipt number | R000061667 |
| Scientific Title | Alteration of T-cell immunity by yogurt containing exopolysaccharide (EPS) |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/30 13:06:14 |
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Basic information
Public title
Alteration of T-cell immunity by yogurt containing exopolysaccharide (EPS)
Acronym
Alteration of T-cell immunity by yogurt
Scientific Title
Alteration of T-cell immunity by yogurt containing exopolysaccharide (EPS)
Scientific Title:Acronym
Alteration of T-cell immunity by yogurt
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Dr. Kawanabe et al. reported that oral intake of exopolysaccharide (EPS) produced by lactic acid bacteria of the genus Lactobacillus increased the proliferation of CCR6-positive CD8+ T cells in Peyer's patches and enhanced the anti-tumor effect of immune checkpoint inhibitors The applicant and his colleagues have reported that oral intake of PD-1 inhibitor (EPS) enhances the anti-tumor effect of immune checkpoint inhibitors.
The applicants have previously reported the discovery of a novel CD4+ T-cell cluster, Th7R, which is expressed as CCR4-CCR6+ in the peripheral blood of patients with advanced stage lung cancer who had responded to PD-1 inhibitors. We have reported that the percentage of Th7R in peripheral blood before treatment can predict the efficacy of immune checkpoint inhibitors in patients with advanced stage non-small cell lung cancer and recurrence-free survival after surgery in patients with early stage lung cancer. In long-term survivors of advanced stage non-small cell lung cancer after immune checkpoint inhibitor therapy and recurrence-free survivors of postoperative early stage non-small cell lung cancer, a high percentage of CCR4-CCR6+ CD4+ T cell clusters were maintained after treatment.
This study aims to analyze the numerical changes in CCR6-positive T cells including Th7R by analyzing the peripheral blood of lung cancer patients who consume Meiji Probio Yogurt R-1, a food containing this EPS, over time.
Basic objectives2
Others
Basic objectives -Others
1. PBMCs are centrifuged by standard techniques after blood collection and cryopreserved by CellBanker2TM. Whole blood samples will be analyzed within 3 days of storage at room temperature. 2.
2. Whole blood samples will be analyzed by flow cytometry for T-cell clusters and other cellular components on behalf of Immunity Research, Inc.
3. Frozen blood samples collected from BD Vacutina CPT blood collection tubes will be subjected to immune cell cluster analysis by mass cytometry after regenerative culture. 4) The mRNA expression of isolated T cells will be analyzed.
4. mRNA expression analysis of isolated T cells and T cell receptor repertoire analysis will be performed using single cell RNA sequencing.
5. Immunohistochemical staining analysis of tissue samples
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
CCR6-positive T cells (CD8+, CD4+) in blood
Key secondary outcomes
Changes in T-cell cluster proportions, changes in expression of functional molecules in each T-cell cluster, immunohistochemical staining analysis of lung cancer biopsy specimens
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test Food Meiji Probio Yogurt R-1 Drink Type 112 g (provided free of charge by Meiji Holdings)
Consume one bottle of the test food once a day for 28 days. The time of intake is free.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with non-small cell lung cancer
(2) Patients who are 20 years of age or older at the time of consent
(3) Patients whose written consent for this study has been obtained.
Key exclusion criteria
(1) Patients with psychosis/psychiatric symptoms that make it difficult for them to participate in this study
(2) Patients with milk allergy
(3) Patients with poorly controlled diabetes mellitus
(4) Patients who do not wish to consume Meiji Probio Yogurt R-1
(5) Other patients who are deemed inappropriate for the study by the physician in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kagamu |
Organization
Saitama Medical University International Medical Center
Division name
Div. of Respiratory Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka city, Saitama pref.
TEL
042-984-4581
kagamu19@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hisao |
| Middle name | |
| Last name | Imai |
Organization
Saitama Medical University International Medical Center
Division name
Div. of Respiratory Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka city, Saitama pref.
TEL
042-984-4511
Homepage URL
hisao725@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co.
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
Saitama Medical University International Medical Center Clinical Research IRB
Address
1397-1 Yamane, Hidaka city, Saitama pref.
Tel
042-984-4523
imc_irb@saitama-med.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
| 2024 | 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
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061667
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