UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043839 |
|---|---|
| Receipt number | 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 | 2022/04/06 09:09:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Hiroki.Takano@jp.nestle.com
Sponsor or person
Institute
Niigata Prefectural Kakizaki Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050033
