UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023901
Receipt No. 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 2019/01/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Tetsuji Okamoto
Organization Hiroshima University Graduate School of Biomedical & Health Sciences
Division name Division of Applied Life Sciences, Institute of Biomedical & Health Sciences, Department of Molecular Oral Medicine and Maxillofacial Surgery
Zip code
Address 1-2-3 Kasumi Minami-ward Hiroshima-city Hiroshima-prefecture, Japan 7348551
TEL 082-257-5667
Email tetsuok@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryouji Tani
Organization Hiroshima University Hospital
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 1-2-3 Kasumi Minami-ward Hiroshima-city Hiroshima-prefecture, Japan 7348551
TEL 082-257-5667
Homepage URL
Email ryouji@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 02 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.