UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035244 |
|---|---|
| Receipt number | R000040159 |
| Scientific Title | A verification study for improving the intestinal environment with consumption of the test food in healthy subjects: an open-label trial |
| Date of disclosure of the study information | 2018/12/13 |
| Last modified on | 2019/10/25 18:34:42 |
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Basic information
Public title
A verification study for improving the intestinal environment with consumption of the test food in healthy subjects: an open-label trial
Acronym
A verification study for improving the intestinal environment with consumption of the test food in healthy subjects
Scientific Title
A verification study for improving the intestinal environment with consumption of the test food in healthy subjects: an open-label trial
Scientific Title:Acronym
A verification study for improving the intestinal environment with consumption of the test food in healthy subjects
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the test food on improving intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Defecation days
2. Defecation frequency
3. Amount of defecation
4. Shape of stool
5. Smell of stool
6. Exhilarating feeling
*1-6 Record the diary from a week before screening (before consumption) to the day before screening (before consumption) and from a week before consuming to the day before 4 weeks after consuming
Key secondary outcomes
1. Firmicutes
2. Bacteroidetes
3. Actinobacteria
4. Proteobacteria
5. Lactobacillaceae
6. Bacteroidaceae
7. Lactobacillus
8. Clostridium
9. Roseburia
10. Ruminococcus
11. Eubacterium
12. Bifidobacterium
13. Bacteroides
14. Anaerostipes
15. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
16. Bristol stool scale
17. Succinic acid
18. Lactic acid
19. Formic acid
20. Acetic acid
21. Propionic acid
22. Isobutyric acid
23. n-Butyric acid
24. Isovaleric acid
25. n-Valeric acid
26. Indole
27. Skatole
*1-14 Analyze the intestinal environment by metagenomics
*1-14 Calculate the abundance ratio of each bacterium
*1-15, 17-27 Assess the measured value at screening (before consumption) and at 2 weeks after consumption and calculate the amount of change.
*16 Assess the measured value at screening (before consumption) and at 2 weeks after consumption.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 2 weeks
Test food: Manda Koso
Administration: Take 5 packs per day after breakfast. Take the packs with water as necessary.
* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult subjects who defecate three to five times per week
2. Subjects who are judged as eligible to participate in the study by the physician
3. Subjects who have relatively few defecation frequency at a week before screening (before consumption)
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements
6. Subjects who are allergic to medicines and/or the test food related products especially orange, walnut, sesame seeds, soybean, banana, and apple
7. Subjects who are pregnant, breast-feeding, or planning to become pregnant
8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
9. Subjects who are ineligibility to participate in the study based on the evaluation of the physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
MANDA FERMENTATION CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
info@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 13 | 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
11
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 | 11 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 13 | Day |
Last modified on
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040159
