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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011380
Receipt No. R000013326
Scientific Title Studies on the effects of polydextrose intake on constipation in Japanese dialysis patients: a triple-blind randomized controlled trial
Date of disclosure of the study information 2013/08/11
Last modified on 2015/08/23

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Basic information
Public title Studies on the effects of polydextrose intake on constipation in Japanese dialysis patients: a triple-blind randomized controlled trial
Acronym Dietary fiber for constipation in hemodialysis patients
Scientific Title Studies on the effects of polydextrose intake on constipation in Japanese dialysis patients: a triple-blind randomized controlled trial
Scientific Title:Acronym Dietary fiber for constipation in hemodialysis patients
Region
Japan

Condition
Condition Constipation in chronic hemodialysis patients
Classification by specialty
Gastroenterology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether administration of a mini-jelly containing a dietary fiber (polydextrose; 10 g/day) improve the function of bowel movements in chronic hemodialysis patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of bowel movements
Key secondary outcomes #Blood biochemistry (BUN,Cr,Ca,P,Alb, hepatic function)
#Dose and usage frequency of medicines for constipation
#Stool form and abdominal symptom
#Side effects of a dietary fiber

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Mini-jelly containing polydextrose (10g/day)
Interventions/Control_2 Placebo (mini-jelly without polydextrose)
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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Chronic hemodialysis patients with constipation
Key exclusion criteria 1) Patients with organic bowel diseases (e.g.; inflammatory bowel disease or colon cancer)
2) Patients who start or change the usage of P, K, cholesterol-binding agents during the study
3) Patients already treated with dietary fibers or Lactobacillus preparations as a supplement
4) Patients hospitalized during the study
5) When an appearance of side effects which seem to be related with dietary fiber mini-jelly or the placebo jelly during the study
6) Patients uncontrolled by hemodialysis during the study
7) Patients showing remarkably poor bowel movements during the study
8) Patients determined by doctors that the study continuation is inappropriate
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikiko Shimada
Organization Hidaka Rehabilitation Hospital
Division name Department of Nutrition
Zip code
Address 2204 Maniwa,Yoshii, Takasaki, Gumma,370-2104, Japan
TEL 027-388-2005
Email reha-eiyo@hidaka-kai.com

Public contact
Name of contact person
1st name
Middle name
Last name Mikiko Shimada
Organization Hidaka rehabilitation hospital
Division name Department of Nutrition
Zip code
Address 2204 Maniwa,Yoshii, Takasaki, Gumma,370-2104, Japan
TEL 027-388-2005
Homepage URL
Email reha-eiyo@hidaka-kai.com

Sponsor
Institute Heisei Hidaka clinic
Institute
Department

Funding Source
Organization Medical Corporations Heisei Hidaka clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo University of Agriculture
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 平成日高クリニック

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 11 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
 The PDX group had significantly increased stool frequency compared to before the PDX intake period: 7.0, 5.0, 8.0, 8.5 bowel movements per week during the PDX study period (week 1-week 4) and 7.3 bowel movements after the end of the study period (p < 0.01).
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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2013 Year 08 Month 30 Day
Date of closure to data entry
2013 Year 09 Month 20 Day
Date trial data considered complete
Date analysis concluded
2013 Year 11 Month 30 Day

Other
Other related information The PDX group showed no significant change was observed in the stool score. While the total energy and macronutrient intake levels were unchanged during the study, paired t-test analysis showed that retinol activity equivalents intake was significantly increased in the PDX group.
Clinical biochemistry indexes (e.g., measures of liver and renal function, blood electrolytes, fasting blood glucose, triglyceride, cholesterol, and serum glycoalbumin) did not change significantly after PDX intake for 28 days.

Management information
Registered date
2013 Year 08 Month 05 Day
Last modified on
2015 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013326

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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