Subjects with a tendency for constipation
Conditions
Interventions
Ingestion of lactic acid bacteria beverage containing Lactobacillus plantarum LP14 for 2 weeks
Ingestion of placebo beverage without Lactobacillus plantarum LP14 for 2 weeks
Sponsors
TTC Co., Ltd.
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 regularly using drugs (constipation drugs, intestinal drugs, etc.) , health foods (senna tea, kefir, etc.), or foods for specified health use (indigestible dextrin, chitosan, oligosaccharides, etc.) (2) Subjects having a large amount of foods such as lactic acid bacteria beverage, food containing lactic acid bacteria (yogurt, kimchi, pickles, sushi fermented with fish and vegetables, etc.), lactic acid bacteria preparation, dietary fiber enriched food, and oligosaccharides more than three times a week (3) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (4) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy) (5) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases (6) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (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 having a disease requiring regular medication or a history of serious diseases for which medication was required (10) Subjects who have participated in other clinical studies (11) Subjects who intend to become pregnant or lactating (12) Subjects judged as unsuitable for the study by physician for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency, defecation days, intestinal microflora | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool output, fecal condition, quantitative analysis of intestinal microflora (total anaerobes, Bifidobacterium, Clostridium perfringens), fecal water content, fecal pH | — |
Countries
Japan
Contacts
Public ContactMika Watanabe
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed