A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects.

A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects. - A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034695

Enrollment

Registered

2018-10-31

Start date

2018-11-01

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

None listed

Interventions

Oral intake of lactic acid bacteria (one tablet per day for 12 months)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Male and female subjects whose ages are over 20 years old (2) Subjects judged as lower levels of bifidobacteria in their intestines by the investigator. (3) Subjects who participate in this study with a written informed concent

Exclusion criteria

Exclusion criteria: (1) Subjects who have consumed the lactic acid bacteria used in this clinical trial on a daily basis (2) Subjects who are in pregnant or plan to get pregnant, or who are breastfeeding (3) Patients with cancer who have taken radiotherapy, anti-cancer agents and/or hormone agents (4) Patients with thyroid disease who have taken medicines such as Thyradin (5) Patients with rheumatoid arthritis who have taken medicines such as Rheumatrex (6) Subjects who are at risk of having allergic symptoms to test product of this clinical trial (7) Subjects who are participating in the other clinical trial (8) Subjects judged as unsuitable for this clinical trial by the investigator or sub investigator.

Design outcomes

Primary

Measure	Time frame
At the 0th, 3th, 6th and 12th month of the intervention (1) Intestinal flora analysis (stool tests) (2) Immune functions (blood T cell number, PHA induced T cell proliferation)	—

Secondary

Measure	Time frame
At the 0th, 3th, 6th and 12th month of the intervention (1) Health conditions (inquiry consultation, physical inspection, questionnaire of dietary habits) (2) Hematology, serum biochemistry, and urinalysis (3) fecal IgA concentrations (4) fecal short-chain fatty acid	—

Countries

Japan

Contacts

Public ContactHiroko Nakai

House Wellness Foods Corporation Research and Development Institute

hiroko-nakai@house-wf.co.jp072-778-1127

Outcome results