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A clinical study for evaluating the effect of intake of Kefir on oral flora and intestinal flora in oral cancer patients

A clinical study for evaluating the effect of intake of Kefir on oral flora and intestinal flora in oral cancer patients - Kefir clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023901
Enrollment
45
Registered
2016-09-30
Start date
2016-09-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral cancer

Interventions

Kefir intake group(4 to 12 weeks) Kefir long-term intake group (5 years) Non-intake group

Sponsors

Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactRyouji Tani

Hiroshima University Department of Oral Oncology, Graduate School of Biomedical and Health Sciences

ryouji@hiroshima-u.ac.jp082-257-5667

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026