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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033185
Receipt No. 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

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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
Email 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
Email yuta-y@wakayama-med.ac.jp

Sponsor
Institute Second Lecture of Internal Medicine, Wakayama Medical University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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