UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041384 |
|---|---|
| Receipt number | R000047119 |
| Scientific Title | The Effect of Fruit Extract on Chronic Constipation and Intestinal Flora -A Randomized, Double blind, Placebo Controlled, Parallel Group Trial- |
| Date of disclosure of the study information | 2020/08/14 |
| Last modified on | 2022/04/08 10:49:23 |
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Basic information
Public title
The Effect of Fruit Extract on Chronic Constipation and Intestinal Flora -A Randomized, Double blind, Placebo Controlled, Parallel Group Trial-
Acronym
The Effect of Fruit Extract on Chronic Constipation and Intestinal Flora
Scientific Title
The Effect of Fruit Extract on Chronic Constipation and Intestinal Flora -A Randomized, Double blind, Placebo Controlled, Parallel Group Trial-
Scientific Title:Acronym
The Effect of Fruit Extract on Chronic Constipation and Intestinal Flora
Region
| Japan |
Condition
Condition
Chronic Constipation
Irritable Bowel Syndrome with Constipation (IBS-C)
Functional Constipation (FC)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Fruit Extract for chronic constipation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel Movement (0, 4, 8w)
Bristol Stool Form Scale (0, 4, 8w)
Key secondary outcomes
Type of intestinal bacterial flora (0, 4, 8w)
Stool metabolome analysis (0, 4, 8w)
Gastrointestinal Symptom Rating Scale (GSRS) (0, 4, 8w)
Subjective indicator survey (0, 4, 8w)
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Fruit Extract 54g per day for 8 weeks
Interventions/Control_2
Placebo drink 54g per day for 8 weeks
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Male and Female, aged 20-75 years
(2)Subjects who have subjective symptoms of constipation (Gastrointestinal Symptom Rating Scale;GSRS)
(3)Subjects who have less than three bowel movements per week or fall under the Bristol Stool Form Scale 1 or 2
(4)Constipation symptoms occur more than six months ago and have symptoms for the last three months
(5)Subjects who has written consent for participation in the study
Key exclusion criteria
(1)Subjects with a history of diabetes, cirrhosis, chronic hepatitis, renal failure, heart failure, cerebral infarction, cerebral hemorrhage, myocardial infarction, angina pectoris, a history of cancer, or a history of surgery of the digestive system (esophagus, stomach, duodenum, small intestine, large intestine, rectal rectal, gallbladder, pancreas)
(2)Subjects who have been pointed out abnormalities in liver function and renal function test values in the last three months
(3)Subjects who currently have a disease under treatment
(4)Subjects with fruit allergies
(5)Subjects who have taken either acid secretion inhibitors, antibiotics, or laxatives within the past three months
(6)Subjects who are consuming excessive alcohol
(7)a pregnant person, or a subject who is expected to become pregnant or breast-feeding
(8)Subjects who are participating in other clinical trials or scheduled to participate in the trial or are less than three months after the end of the trial
(9)Subjects with cold symptoms within the past month
(10)Subjects diagnosed with new coronavirus from within the past three months
(11)Subjects judged inappropriate by the doctor responsible for the examination
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Medical corporation Kanonkai, Miura clinic
Division name
Internal medicine
Zip code
530-0044
Address
Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-6135-5200
info@miula.co.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Koyama |
Organization
Miki Corporation
Division name
Institure for Health science
Zip code
663-8142
Address
12-4, Naruohama 3, Nishinomiya, Hyogo
TEL
0798431870
Homepage URL
koyama@mikiprune.co.jp
Sponsor or person
Institute
Oneness Support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Miki Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6135-5200
koyama@mikiprune.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 14 | 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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 11 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047119
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