The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study

The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study - The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027398

Enrollment

100

Registered

2017-12-28

Start date

2017-05-21

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

Individuals with a tendency for constipation

Interventions

intake of a test food containing with lactobacillus for 2 consecutive weeks intake of a placebo for 2 consecutive weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Males and females from 20 to 64 years of age (2) Subjects with a tendency for constipation at three to five times of defecation per week

Exclusion criteria

Exclusion criteria: (1) Subjects who routinely takes foods or medicines containing of Lactobacillus (2) Subjects who routinely takes foods or medicines containing of Bacillus subtilis var. natto (3) Subjects who routinely takes foods or medicines affecting the test result (4) Subjects having diseases affecting bowel movement or a history of these diseases (5) Subjects having possibilities for emerging allergy related to the study (6) Subjects who has asthma or the possibility of asthma (7) Subjects who is employed on a pre-dawn shift or on night duty more than 2 times (8) Subjects who is planned to go overseas (9) Subjects who has treatment or a history of serious disease (10) Subjects who has treatment of disease (11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on screening test (12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (15) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

Measure	Time frame
defecation frequency, stool output	—

Secondary

Measure	Time frame
defecation days, fecal condition	—

Countries

Japan

Contacts

Public ContactShingo Yamamichi

TTC Co.,Ltd. Clinical Research Planning Department

s.yamamichi@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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