UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030184 |
|---|---|
| Receipt number | 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 | 2020/06/14 08:55:41 |
* 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 | Sachiyo |
| Middle name | |
| Last name | Sakaguchi |
Organization
Medical Corporation K. Medical Office
Division name
TOC Building Clinic
Zip code
141-0031
Address
7-22-17 Nishigotanda Shinagawa-ku Tokyo
TEL
03-3494-2491
kenshin@kmo.or.jp
Public contact
Name of contact person
| 1st name | Zenta |
| Middle name | |
| Last name | Yasukawa |
Organization
Taiyo Kagaku Co., Ltd.
Division name
Nutrition division
Zip code
510-0844
Address
1-3, Takara-cho, Yokkaichi-shi, Mie,
TEL
059-347-5411
Homepage URL
zyasukawa@taiyokagaku.co.jp
Sponsor or person
Institute
imeQ Co.Ltd.
Institute
Department
Personal name
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
SUDA Clinic Institutional Review Board
Address
2-8-14 Takadanobaba, Shinjuku-ku, Tokyo
Tel
03-6205-6222
m-yamada@imeq.co.jp
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
None
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6769658/
Number of participants that the trial has enrolled
44
Results
Intake of the PHGG for 3 months significantly improved stool form, evaluated using BSS, and had no effects on stool frequency. BSS was significantly normalized in the group consuming the PHGG compared with the placebo. Comprehensive fecal microbiome analysis by the 16S rRNA-sequence method detected significant changes in the ratio of some bacteria, such as an increase of Bifidobacterium (p < 0.05) in the PHGG group.
Results date posted
| 2020 | Year | 06 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
subjects who were healthy with a loose stool
Participant flow
Forty-four volunteers were selected as study subjects from eighty-eight healthy Japanese male and female.
Adverse events
None.
Outcome measures
Fecal characteristics, fecal frequency, serum bile acids, QoL etc
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
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nutrients. 2019 Sep; 11(9): 2170.
doi: 10.3390/nu11092170
Management information
Registered date
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034461
