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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043839
Receipt No. R000050033
Scientific Title Effect of Partially Hydrolyzed Guar Gum (PHGG) intake by elderly people with recurrent urinary tract infections on prevention of recurrent urinary tract infections
Date of disclosure of the study information 2021/04/05
Last modified on 2021/04/05

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Basic information
Public title Effect of Partially Hydrolyzed Guar Gum (PHGG) intake by elderly people with recurrent urinary tract infections on prevention of recurrent urinary tract infections
Acronym Effect of Partially Hydrolyzed Guar Gum (PHGG) intake on prevention of recurrent urinary tract infections
Scientific Title Effect of Partially Hydrolyzed Guar Gum (PHGG) intake by elderly people with recurrent urinary tract infections on prevention of recurrent urinary tract infections
Scientific Title:Acronym Effect of Partially Hydrolyzed Guar Gum (PHGG) intake on prevention of recurrent urinary tract infections
Region
Japan

Condition
Condition Urinary-tract infection
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elderly patients with recurrent urinary tract infections will take PHGG and the frequency of recurrent urinary tract infections before and after PHGG intake will be evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of urinary tract infections
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Patients who have been visiting our hospital for more than one year or who are receiving nursing care services at a nearby nursing home
(2) Men and women who are 65 years old or older
(3) Patients who have had two or more urinary tract infections in the past year prior to obtaining consent
(4) Patients who understand the contents of the study and are able to give their consent in person or by a substitute
Key exclusion criteria (1) Patients with a risk of gastrointestinal stenosis, including ileus
(2) Patients with extreme diarrhea
(3) Patients with urethritis, prostatitis, or epididymitis
(4) Patients with complications such as urinary tract stones, urinary tract tumors, hydro nephrosis, etc. that require treatment
(5) Patients with other severe underlying diseases or complications
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kyuma
Middle name
Last name Ota
Organization Niigata Prefectural Kakizaki Hospital
Division name Directer
Zip code 949-3216
Address 6412-1 Kakizaki, Kakizaki-ku, Jyouetsu-city, Niigata
TEL 025-536-3131
Email inchou@kakizaki-hp.niigata.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Takano
Organization Nestle Health Science Company, Nestle Japan Ltd
Division name Marketing & Medical Affairs
Zip code 140-0002
Address 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL 03-5769-6227
Homepage URL
Email Hiroki.Takano@jp.nestle.com

Sponsor
Institute Niigata Prefectural Kakizaki Hospital
Institute
Department

Funding Source
Organization Nestle Health Science Company, Nestle Japan Ltd
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 Niigata Prefectural Kakizaki Hospital
Address 6412-1 Kakizaki, Kakizaki-ku, Jyouetsu-city, Niigata
Tel 025-536-3131
Email inchou@kakizaki-hp.niigata.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
2021 Year 04 Month 05 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 Enrolling by invitation
Date of protocol fixation
2021 Year 01 Month 22 Day
Date of IRB
2021 Year 01 Month 28 Day
Anticipated trial start date
2021 Year 02 Month 15 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 04 Month 05 Day
Last modified on
2021 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050033

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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