UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023901 |
|---|---|
| Receipt number | R000027526 |
| Scientific Title | A clinical study for evaluating the effect of intake of Kefir on oral flora and intestinal flora in oral cancer patients |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2025/03/14 19:12:57 |
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Basic information
Public title
A clinical study for evaluating the effect of intake of Kefir on oral flora and intestinal flora in oral cancer patients
Acronym
Kefir clinical study
Scientific Title
A clinical study for evaluating the effect of intake of Kefir on oral flora and intestinal flora in oral cancer patients
Scientific Title:Acronym
Kefir clinical study
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We grouped randomly oral cancer patients into three groups, Kefir intake group, Kefir long-term intake group, Non-intake group, research the temporal genome analysis for the oral flora and the intestinal flora of each group, and we analyze whether the intake of Kefir and oral cancer treatment how they affect the oral and intestinal flora. In addition, we also investigate the influence of the intake of kefir has on the therapeutic effect of oral cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of the oral flora and intestinal flora
Changes in the immune markers such as cell-mediated immunity
Response Evaluation Criteria in Solid Tumors
Overall survival time, Progression-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Kefir intake group(4 to 12 weeks)
Interventions/Control_2
Kefir long-term intake group (5 years)
Interventions/Control_3
Non-intake group
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have been confirmed diagnosed with histologically oral cancer.
Untreated case.
Patients with measurable lesions that meet the Response Evaluation Criteria in Solid Tumors version1.1.
Age at the time of consent acquisition year is 20 years of age or older, less than 80 years old.
Performance Status of patient is 0, 1, 2.
Major organs, bone marrow, heart, and kidney, function is sufficiently held, that meet the criteria of the following clinical examination within two weeks prior to the registration.
1. leukocyte number is over 4,000 / mm3 and under 12,000 / mm3.
2. platelet count over 100,000 / mm3
3. AST is less than 3 times the normal value facility.
4. total bilirubin is under 1.5mg / dl
5. eGFR is over 60 mL / min / 1.73 m2.
6. On electrocardiogram, no abnormality was observed in need of treatment.
Patients written consent has been obtained from person.
Key exclusion criteria
Patients with active double cancer.
Patients with serious complications, intestinal paralysis, intestinal obstruction, interstitial pneumonia, lung fibrosis, uncontrollable diabetes, heart failure, kidney failure, liver failure.
Patients with a hypersensitivity of iodinated contrast agent,milk and dairy products.
Patients with severe mental disorders
Patients and lactating women that might be pregnant or are pregnant
Others, doctor has determined to be inappropriate as a subject of this study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Ryouji |
| Middle name | |
| Last name | Tani |
Organization
Hiroshima University
Division name
Department of Oral Oncology, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi Minami-ward Hiroshima-city Hiroshima-prefecture, Japan 7348551
TEL
082-257-5667
ryouji@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryouji |
| Middle name | |
| Last name | Tani |
Organization
Hiroshima University
Division name
Department of Oral Oncology, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi Minami-ward Hiroshima-city Hiroshima-prefecture, Japan 7348551
TEL
082-257-5667
Homepage URL
ryouji@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Ryouji Tani
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel
(082)257-1947
iryo-sinsa@office.hiroshima-u.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
| 2016 | Year | 09 | Month | 30 | 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
45
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027526
