UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014256 |
|---|---|
| Receipt number | R000016603 |
| Scientific Title | Double-blind, parallel-group, placebo-controlled study to compare a four week continuous ingestion effect of Champignon extract on fecal odor, body odor, oral odor and enteric environment of the subjects. |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2015/04/21 11:36:39 |
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Basic information
Public title
Double-blind, parallel-group, placebo-controlled study to compare a four week continuous ingestion effect of Champignon extract on fecal odor, body odor, oral odor and enteric environment of the subjects.
Acronym
Effects of Champignon extract on fecal odor, body odor, oral odor and enteric environment of the subjects.
Scientific Title
Double-blind, parallel-group, placebo-controlled study to compare a four week continuous ingestion effect of Champignon extract on fecal odor, body odor, oral odor and enteric environment of the subjects.
Scientific Title:Acronym
Effects of Champignon extract on fecal odor, body odor, oral odor and enteric environment of the subjects.
Region
| Japan |
Condition
Condition
Fecal odor, body odor, oral odor
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement of fecal odor, body odor, oral odor and enteric environment based on a four week continuous ingestion of Champignon extract, and to study its secondary effect as an immunostimulant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Fecal analysis (odor component, intestinal bacterial flora), fecal diary, VAS questionnaire for body odor, oral odor and bowel movement.
Key secondary outcomes
Natural killer cell activity
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
YES
Concealment
Central registration
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Two grams of powder containing 50mg of Champignon extract, ingested daily over a period of four weeks.
Interventions/Control_2
Two grams of powder containing 200mg of Champignon extract, ingested daily over a period of four weeks.
Interventions/Control_3
Two grams of powder containing 500mg of Champignon extract, ingested daily over a period of four weeks.
Interventions/Control_4
Two grams of powder containing 1000mg of Champignon extract, ingested daily over a period of four weeks.
Interventions/Control_5
Two grams of powder containing dextrin, ingested daily over a period of four weeks.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects who are worried about fecal odor, body odor or oral odor
2.A subject with an observer, for objectively evaluating above odors.
Key exclusion criteria
1.Subjects who are suffering from
serious cerebrovascular disease, heart
disease, liver disease, renal disease,
gastrointestinal disease or any infectious
disease which needs immediate reporting.
2.Subjects with a clinical history of
gastrointestinal cancer or are currently
under its medical treatment.
3.Subjects having a clinical history of
gastrectomy, gastrointestinal suture,
bowel resection or any major surgery in
the digestive system.
4.Subjects having a gastrointestinal
disorder, irritable bowel syndrome,
inflammatory bowel syndrome etc.
5.Subjects under the medication for
bowel movements (such as antibiotics,
laxatives, medicine for constipation) or
using functional foods and supplements
(containing lactic acid bacteria,
bifidobacterium, oligosaccharides, dietary
fiber etc.)
6.Subjects who will undergo dental
treatment during this study period.
7.Subjects with frequent complaints of post-menopausal symptoms.
8.Subjects with unusually high and/or
low blood pressure, or with abnormal
hematological data.
9.Subjects with serious anemia.
10.Subjects with a history of allergy to
medicine and food (especially mushroom).
11.Subjects who have defecation
frequency less than four times per week
or those who suffer from diarrhea.
12.Subjects who are heavy smokers or
alcoholics, or exhibit irregular pattern in their lifestyles such as meals or sleep etc.
13.Subject who has donated 400ml
whole blood within past 12 weeks or
200ml within past 4 weeks or who has
donated plasma or platelets within past 2
weeks prior to this study.
14.Subjects who are pregnant or under
lactation, or who expect to get pregnant
during this study period.
15.Subject who has participated in
other clinical trials within past one
month or is currently undergoing any
clinical trial.
16.Subjects who are judged ineligible by
our physician.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, 069-8585, Hokkaido
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, 069-8585, Hokkaido
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
COSMO BIO Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 06 | Month | 16 | 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
| 2014 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 04 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 11 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 13 | Day |
Last modified on
| 2015 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016603
