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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031266
Receipt No. R000035698
Scientific Title Pre-examination: Effect of dietary Mozuku powder on gut microbiota composition.
Date of disclosure of the study information 2018/02/15
Last modified on 2018/06/13

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Basic information
Public title Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Acronym Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Scientific Title Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Scientific Title:Acronym Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Region
Japan

Condition
Condition Because it is a test for healthy subjects, there is no target disease.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Dietary fiber is metabolized by intestinal fermentation of more than 100 trillion bacteria present in the intestinal tract without being decomposed by the digestive juice at the upper part of the gastrointestinal tract, and is converted into a useful metabolite for the health of the host. In addition to being used as an energy source in intestinal mucosa, this metabolite is known to inhibit proliferation of intestinal putrefactive bacteria, etc., to prepare intestinal environment, promote peristaltic movement of intestine, and promote defecation.
Okinawa virgin soybean is a food with a high content of dietary fiber, and an effect of improving the number of times of defecation by reporting that 2.4 g of dry powder is taken a day is reported. However, since there is no report on intestinal bacterial flora analysis due to ingestion of this powder, a comparative test between the test food intake group containing the dry powder of Okinawawa mozuku and the control test food intake group was planned and the intestinal flora By analysis, Bifidobacterium occupancy ratio to total number of bacteria is determined, and the intestinal action of Okinawan mozuku derived dietary fiber is examined.
Basic objectives2 Others
Basic objectives -Others usefulness
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of Bifidobacterium to the number of intestinal inner layer bacteria
Key secondary outcomes Defecation status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Dry mozuku powder blending sprinkle
Interventions/Control_2 Dry mozuku powder non-blended sprinkle
Interventions/Control_3
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Healthy people who do not have severe disease

2. A person who wishes voluntarily to participate in clinical trials in men and women aged 20 years or over and under 65 years old and who can obtain written informed consent

3.Those who can withdraw laxatives, constipation drugs, supplements expected to have bowel improvement effect, health tea etc during the examination period.

4. people with constipation tendency (stool frequency ~ 3 times / week, excluding severe constipation)

5. Those who do not take supplements that are predicted to constantly improve constipation medicine and bowel movement within the first month

6. Who can keep daily lifestyle habits constant during the examination period

7. Study participation of people who are treating mild chronic diseases (hypertension, hyperlipemia, etc.) shall be able to participate at the discretion of the investigator
Key exclusion criteria 1. People with severe diseases (heart disease, liver disease, kidney disease, cancer, etc.) and mental illness.

2. People with digestive system disease history and surgery history of digestive organs.

3. constipation who may be caused by diseases (colorectal cancer, Crohn's disease, etc.) and drugs (anticholinergics, antidepressants, etc.)

4. Those who can not maintain everyday life habits with large changes in diet and exercise.

5. If you work on shifts, work at midnight.]

6. Persons who constantly take on laxatives, constipation medicine and supplements, health tea etc. expected to improve bowel movement regularly or within 1 month of the month within 1 month.

7. Possible food allergy and drug allergy to the test food.

8. Pregnant women / lactating women and those who wish pregnant during the examination period.

9. Others who have made the examination responsible doctor ineligible for participation in this exam.

10. Those who participate in other clinical trials within the past month.
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ono, Seiichi
Organization Wellbe Inc.
Division name Clinical Research Division
Zip code
Address Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan
TEL 098-988-9007
Email abe@well-b.jp

Public contact
Name of contact person
1st name
Middle name
Last name Abe, Hiroyuki
Organization Wellbe Inc.
Division name Clinical Research Division
Zip code
Address Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan
TEL 098-988-9007
Homepage URL
Email abe@well-b.jp

Sponsor
Institute Wellbe Inc.
Institute
Department

Funding Source
Organization Okinawa Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 02 Month 15 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 03 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035698

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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