UMIN-CTR Clinical Trial

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	7
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	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	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 04 Month 30 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information	None

Management information
Registered date	2021 Year 04 Month 05 Day
Last modified on	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050033