healthy adults with a tendency for constipation
Conditions
Interventions
Take 3 hard capsules containing Bifidobacterium once a day for 4 weeks.
Take 3 hard capsules without Bifidobacterium once a day for 4 weeks.
Sponsors
Transgenic, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 20 to 64 years at the time of consent to participate in the study. 2) Subjects with 3 to 5 bowel movements per week in background survey. 3) Subjects who can visit the testing institution on the scheduled visit date. 4) Subjects who fully understand the purpose and content of the study and agree in writing prior to the start of the study.
Exclusion criteria
Exclusion criteria: 1) Subjects taking medicines/foods that affect the intestinal environment regularly. 2) Subjects with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease. 3) Subjects with chronic diseases and regular users of medicines. 4) Subjects with a history or current history of drug or alcohol dependence 5) Subjects with a history of gastrointestinal disease or surgery that affects digestion, absorption, or defecation. 6) Subjects with food allergies related to the test food. 7) Subjects with extremely irregular daily habits and eating habits (including late-night workers). 8) Subjects who cannot restrict the use of drugs/foods that affect the study after obtaining consent. 9) Subjects with excessive habits of exercise, drinking and smoking. 10) Pregnant or lactating women or women who may become pregnant during the study period. 11) Subjects who have taken or will take antibiotics within 1 month prior to obtaining consent during the study period. 12) Participated, are currently participating, or will participate during the study period, in any other clinical research within 1 month prior to obtaining consent. 13) Subjects who plan to change their lifestyle drastically after obtaining consent and before the end of the study. 14) Subjects who plan to travel abroad after obtaining consent and before the end of the study. 15) Subjects judged to be unsuitable based on their answers to the background questionnaire. 16) Other subjects who are judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and days of defecation per week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation survey, Analysis of the gut microbiota, Fecal counts of Bifidobacterium, Quantity of functional substance in feces, Organic acids in feces, Putrefactive products in feces, Ammonia in feces, Fecal pH, Fecal water content, JPAC-QOL, Stratum corneum moisture content, and Transepidermal water loss. | — |
Countries
Japan
Contacts
Public ContactShimpei Tomita
Transgenic, Inc. Clinical Dept.
Outcome results
None listed