UMIN-CTR Clinical Trial

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