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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023861
Receipt No. R000027490
Scientific Title The clinical evaluation about the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Date of disclosure of the study information 2016/09/01
Last modified on 2018/05/24

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Basic information
Public title The clinical evaluation about the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Acronym The clinical evaluation of the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Scientific Title The clinical evaluation about the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Sadao Yoshida
Organization Okinawa Medical Hospital
Division name internal medicine
Zip code
Address Nishihara2310, Sashiki Tsuhako, Nanjyo-shi, Okinawa, 901-1414, Japan
TEL 098-947-3555
Email info@rinsyou-siken.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sadao Yoshida
Organization Okinawa Medical Hospital
Division name internal medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 22 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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