UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035613
Receipt No. R000040573
Scientific Title Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2019/01/21
Last modified on 2019/03/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym Effects of consumption of the test food on bowel movement and intestinal environment
Scientific Title Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym Effects of consumption of the test food on bowel movement and intestinal environment
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 bowel movement and intestinal environment on the healthy Japanese adult subjects who defecate three to five times per week and do not eat enough fiber
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Defecation frequency

*1 Record the bowel movement 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 (total 3 weeks)
Key secondary outcomes 1. Defecation days
2. Amount of defecation
3. Shape of stool
4. Smell of stool
5. Exhilarating feeling
6. Bifidobacterium
7. Lactobacillales
8. Bacteroides
9. Prevotella
10. Clostridium cluster IV
11. Clostridium cluster IX
12. Clostridium cluster XI
13. Clostridium subcluster XIVa
14. Clostridium cluster XVIII
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. iso-Butyric acid
23. n-Butyric acid
24. iso-Valeric acid
25. n-Valeric acid

*1-5 Record the bowel movement 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 (total 3 weeks)
*6-25 Assess the measured values or the amount of change at screening (before consumption) and at 2 weeks after consumption

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 2 weeks
Test food: Tablets containing mulukhiya
Administration: Take a total of 30 tablets per day between meals with water and no chewing
Interventions/Control_2 Duration: 2 weeks
Test food: Placebo tablets
Administration: Take a total of 30 tablets per day between meals with water and no chewing
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 subjects

2. Japanese adult subjects

3. Subjects who defecate three to five times per week

4. Subjects who do not eat enough fiber in usual dietary life

5. Subjects who are determined as eligible to participate in the study by the physician

6. Subjects who have relatively a few defecation frequencies 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 regularly use anticoagulants, such as warfarin

7. Subjects who are allergic to medicines and/or the test food related products

8. Subjects who are pregnant, breast-feeding, or planning to become pregnant

9. 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

10. Subjects who are ineligibility to participate in the study based on the evaluation of the physician
Target sample size 20

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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization AOTSUBU 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
Email 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
2019 Year 01 Month 21 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 22
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
2019 Year 01 Month 07 Day
Date of IRB
2019 Year 01 Month 07 Day
Anticipated trial start date
2019 Year 01 Month 22 Day
Last follow-up date
2019 Year 04 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 21 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040573

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.