UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033185 |
|---|---|
| Receipt number | R000037666 |
| Scientific Title | The effects of bifidobacterium lactis strain NT and effects of addition to galacto-oligosaccharide on defecation frequency in healthy subjects with low defecation frequency: a randomized, double-blind, placebo-controled, parallel-group trial |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/04/07 17:05:45 |
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Basic information
Public title
The effects of bifidobacterium lactis strain NT and effects of addition to galacto-oligosaccharide on defecation frequency in healthy subjects with low defecation frequency: a randomized, double-blind, placebo-controled, parallel-group trial
Acronym
The effects of bifidobacterium lactis strain NT and effects of addition to galacto-oligosaccharide on defecation frequency in healthy subjects with low defecation frequency: a randomized, double-blind, placebo-controled, parallel-group trial
Scientific Title
The effects of bifidobacterium lactis strain NT and effects of addition to galacto-oligosaccharide on defecation frequency in healthy subjects with low defecation frequency: a randomized, double-blind, placebo-controled, parallel-group trial
Scientific Title:Acronym
The effects of bifidobacterium lactis strain NT and effects of addition to galacto-oligosaccharide on defecation frequency in healthy subjects with low defecation frequency: a randomized, double-blind, placebo-controled, parallel-group trial
Region
| Japan |
Condition
Condition
Subjects who have a tendency to be constipated
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To varidate the effect of frequent bowel movement on intaking capsule food containing Bifidobacterium lactis NT strain or capsule food added galactooligosaccharide to Bifidobacterium lactis NT strain for 2 weeks in adults who defecate twice or three times per week.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of spontaneous bowel movements during the second week of the administration period
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take four capsules containing Bifidobacterium lactis a day
Interventions/Control_2
Take four capsules containing Bifidobacterium lactis and galact-oligo saccaride a day
Interventions/Control_3
Take four placebo capsules a day
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key 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
Key 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
Target sample size
69
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Maekita |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Lecture of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama 641-8509, Japan
TEL
073-441-0627
maekita@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Yamamoto |
Organization
Wakayama Medical University, School of Medicine
Division name
Department of Anatomy and Cell Biology
Zip code
Address
811-1 Kimiidera, Wakayama 641-8509, Japan
TEL
073-441-0616
Homepage URL
yuta-y@wakayama-med.ac.jp
Sponsor or person
Institute
Second Lecture of Internal Medicine, Wakayama Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nitto Pharmaceutical Industries, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 06 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037666
