Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study

Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study - Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028830

Enrollment

Registered

2018-10-25

Start date

2017-08-26

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

Healthy adult

Interventions

Ingestion of the test product for 2 consecutive weeks Ingestion of 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 (three to five times of defecation per week)

Exclusion criteria

Exclusion criteria: (1)Subjects routinely taking medicine or health food which may influence bowel movement and take foods of lactic acid bacteria. (2) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (3) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy) (4) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases (5) Subjects who are under medication or having a history of serious diseases for which medication was required (6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (8) Subjects having possibilities for emerging allergy related to the study (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (10) 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 (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (13) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

Measure	Time frame
Defecation frequency,Defecation days. Evaluate at points of 2-week of consumption.	—

Secondary

Measure	Time frame
Intestinal flora (T-RFLP, Real-Time PCR), Stool output, Fecal condition, Questionnaire	—

Countries

Japan

Contacts

Public ContactChiharu Goto

TTC Co., Ltd. Clinical Research Planning Department

c.goto@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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