UMIN-CTR Clinical Trial

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
Email	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
Email	koyama@mikiprune.co.jp

Sponsor
Institute	Oneness Support Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047119