Subjects who have a tendency to be constipated
Conditions
Interventions
Take four capsules containing Bifidobacterium lactis a day
Take four capsules containing Bifidobacterium lactis and galact-oligo saccaride a day
Take four placebo capsules a day
Sponsors
Second Lecture of Internal Medicine, Wakayama Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male and female from 20 to 60 years old 2. Subjects whose stool frequency is twice or three times per week 3. Subjects who can obtain written consent about the participation of this research
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with constipation or subjects who fit the Rome IV criteria in the interview 2. Subjects who have the history of organic disease in the gastrointestinal tract in the past and present 3. Subjects who diagnosed as kidney disease 4. Subjects who diagnosed as diabetes 5. Subjects who diagnosed with hypothyroidism 6. Subjects who diagnosed with inflammatory disease 7. Subjects who diagnosed with neurological or psychiatric disease 8. Subjects who took antibiotics or probiotics within the past 1 month including present 9. Subjects who take the drugs inducing chronic constipation 10. Subjects who use biological drugs and steroids 11. Subject who take the foods containing lactic acid bacteria or bifidus bacteria routinely 12. Subject who take the health food for constipation improvement routinely 13. Subjects who have a history of allergy to the foods containing lactobacillus or bifidus bacteria 14. Subjects who participating in other clinical tests about food containing probiotics, or who have not been past one month since participation 15. Subjects who cannot stop the use of constipation drugs and that of foods for constipation improvement during the research period 16. Subjects who will travel overseas during the research period 17. Subjects who investigator judge not suitable to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of spontaneous bowel movements during the second week of the administration period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Spontaneous stool frequency during the first week of the administration period 2. The difference of spontaneous stool frequency between the period of first week of the administration period and the period of second week of the observation period 3. The difference of spontaneous stool frequency between the period of second week of the administration period and the period of second week of the observation period 4. Spontaneous stool frequency during the first or second week of the observation period 5. Spontaneous stool frequency without feeling of incomplete evacuation during the first week of the administration period 6. Spontaneous stool frequency without feeling of incomplete evacuation during the second week of the administration period 7. Spontaneous stool frequency without feeling of incomplete evacuation during the first week of the observation period 8. Spontaneous stool frequency without feeling of incomplete evacuation during the second week of the observation period 9. The difference of spontaneous stool frequency between the administration period and the observation period 10. The difference of days when subjects defecate between the administration period and the observation period 11. The difference of average on Bristol stool form scale between the administration period and the observation period 12. The difference of score about straining during bowel movement 13. The difference of score about pain during bowel movement 14. The difference of score about incomplete bowel movement 15. The difference of score at each question of PAC-SYM 16. The ratios of subjects whose scores of PAC-SYM was decreased by more than 0.5 or 1 before and after the administration period 17. The ratio of nonresponder to test food about the effect of constipation improvement 18. The difference of each nutrient calculated by BDHQ between responder and nonresponder in entire or each group 19. The difference of score about stool color before and after the administration period | — |
Countries
Japan
Contacts
Public ContactYuta Yamamoto
Wakayama Medical University, School of Medicine Department of Anatomy and Cell Biology
Outcome results
None listed