UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical evaluation about the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Title of the study (Brief title)	The clinical evaluation of the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Region	Japan

Condition
Condition	Constipation
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess bowel movement improvement effect of dietary fiber-containing jelly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of defecation per day (Defecation rate)
Key secondary outcomes	Defecation frequency, fecal property, amount of feces, number of days and frequency of laxative use

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	One pouch of dietary fiber-containing jelly is to be taken each day on 14 consecutive days after 14 days of non-intake period.
Interventions/Control_2	A total of 100 mL water is to be taken each day on 14 consecutive days after 14 days of non-intake period.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient considered to have functional constipation 2) Patient aware of what and how much he/she takes 3) Patient who has consumed at least 80% of the meal offered before the start of the study 4) Patient who is in a hospital or in a healthcare facility
Key exclusion criteria	1) Patient considered to have organic constipation 2) Patient who has metabolic disorder 3) Patient treated with opium alkaloid, anticholinergic drug, anesthetic drug, hypotensive drug having ganglionic blocking action, or antidepressant drug 4) Patient who has neuropathy 5) Patient who has markedly painful hemorrhoid, anal fissure, or anal fistula, etc. 6) Patient who has artificial anus 7) Patient who developed aspiration pneumonia within one month 8) Patient who takes dietary fiber contained in fluid diet or other food products by 15 g/day or more in total 9) Patient who was determined to be ineligible for the assessment by a doctor
Target sample size	100

Research contact person
Name of lead principal investigator	Sadao Yoshida
Organization	Okinawa Medical Hospital
Division name	internal medicine
Address	Nishihara2310, Sashiki Tsuhako, Nanjyo-shi, Okinawa, 901-1414, Japan
TEL	098-947-3555
Email	info@rinsyou-siken.jp

Public contact
Name of contact person	Sadao Yoshida
Organization	Okinawa Medical Hospital
Division name	internal medicine
Address	Nishihara2310, Sashiki Tsuhako, Nanjyo-shi, Okinawa, 901-1414, Japan
TEL	098-947-3555
Homepage URL
Email	info@rinsyou-siken.jp

Sponsor
Institute	Okinawa Medical Hospital
Institute
Department

Funding Source
Organization	NUTRI 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)

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	2016 Year 09 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 08 Month 22 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027490