UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030184
Receipt No. R000034461
Scientific Title Effects of continuous ingestion of partially hydrolyzed guar gum on soft stool by intestinal bacterial flora
Date of disclosure of the study information 2018/12/01
Last modified on 2019/01/21

* 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 continuous ingestion of partially hydrolyzed guar gum on soft stool by intestinal bacterial flora
Acronym Effects of partially hydrolyzed guar gum on soft stool
Scientific Title Effects of continuous ingestion of partially hydrolyzed guar gum on soft stool by intestinal bacterial flora
Scientific Title:Acronym Effects of partially hydrolyzed guar gum on soft stool
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of effects of food containing partially hydrolyzed guar gum on stool character and intestinal bacterial flora
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bowel Survey
Key secondary outcomes Intestinal bacterial Flora, blood metabolite, questionnaire

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 Prevention
Type of intervention
Food
Interventions/Control_1 Oral intake of the food containing partially hydrolyzed guar gum (continuous)
Interventions/Control_2 Oral intake of placebo food (continuo
us)
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
49 years-old >=
Gender Male and Female
Key inclusion criteria 1. Japanese male and female volunteers
(20 to 49 years).
2. Healthy people.
3. Who has trends of diahhrea.
4. Who can give informed consent by the document based on the individual's intention before the start of the study.
5. Who can visit the clinic during the test period.
Key exclusion criteria People who meet any of the following conditions will be excluded.
1. Who is likely to be inflammatory bowel disease, gastrointestinal ulcers, pancreatitis, celiac disease, lactose intolerance, protozoan infection, parasitic infection, other organic gastrointestinal disease or pregnant women.
2. Who uses commercially available drug or a quasi-drugs, for the prevention and treatment of diarrhea with abdominal pain and abdominal discomfort, on a daily basis.
3. Who is currently going to hospital for the treatment of diarrhea with abdominal pain and abdominal discomfort.
4. Who is judged by principal investigator to require medical treatment because of severe diarrhea with abdominal pain and abdominal discomfort.
5. Who has been diagnosed with irritable bowel syndrome.
6. Who has experienced a gastrointestinal surgery, excluding operation for appendicitis.
7. Who is in breast-feeding or pregnancy, or wishes to become pregnant during the study period.
8. Who has been treated for some systemic disease.
9. Who uses non-steroidal anti-inflammatory drugs, steroids or antibiotics on a daily basis.
10. Who is smoker -excluding who have quitted smoking for one year or more.
11. Who has an abnormality in the blood test excluding who is judged by principal investigator as in range of physiological variation.
12. Who had participated in a clinical trial within 60 days before a screening test.
13. Who is irresponsible-mental illness, dementia etc.
14. Who is sufferring or have sufferred allergic reaction to food or drug.
15. Who is judged as ineligible by principal investigators or researchers.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiyo Sakaguchi
Organization Medical Corporation K. Medical Office
Division name TOC Building Clinic
Zip code
Address 7-22-17 Nishigotanda Shinagawa-ku Tokyo
TEL 03-3494-2491
Email kenshin@kmo.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Zenta Yasukawa
Organization Taiyo Kagaku Co., Ltd.
Division name Nutrition division
Zip code
Address 1-3, Takara-cho, Yokkaichi-shi, Mie,
TEL 059-347-5411
Homepage URL
Email zyasukawa@taiyokagaku.co.jp

Sponsor
Institute imeQ Co.Ltd.
Institute
Department

Funding Source
Organization Taiyo Kagaku Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto Prefectural University of Medicine
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 医療法人社団ケイメディカルオフィス(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 12 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
2017 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.