UMIN-CTR Clinical Trial

Basic information
Public title	In Vivo Antimicrobial Activity of Green Tea within Percutaneous Endoscopic Gastrostomy (PEG) Tubes: A Randomized Controlled Study
Acronym	In Vivo Antimicrobial Activity of Green Tea within Percutaneous Endoscopic Gastrostomy (PEG) Tubes
Scientific Title	In Vivo Antimicrobial Activity of Green Tea within Percutaneous Endoscopic Gastrostomy (PEG) Tubes: A Randomized Controlled Study
Scientific Title:Acronym	In Vivo Antimicrobial Activity of Green Tea within Percutaneous Endoscopic Gastrostomy (PEG) Tubes
Region	Japan

Condition
Condition	Patients who require percutaneous endoscopic gastrostomy (PEG) insertion
Classification by specialty	Medicine in general Gastrointestinal surgery Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the antimicrobial activity of green tea within PEG tubes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Strains of bacterial colonies Number of bacterial colonies
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	After feeding, nurses rinse within the PEG tube by water, and inject 15ml green tea for 3 weeks. Tea catechins-enriched beverage is used.
Interventions/Control_2	usual care
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	Patients aged over 65 years who require percutaneous endoscopic gastrostomy (PEG) insertion at Hitachikoh Hospital in Japan
Key exclusion criteria	Patients who take ferric medicine, are restless, and/or have sleep disturbance
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuka Kanoya
Organization	Yokohama City University
Division name	School of Medicine
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, JAPAN
TEL	045-787-2525
Email	ykano@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akiyo Sasaki-Otomaru
Organization	Yokohama City University
Division name	School of Medicine
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, JAPAN
TEL	045-787-2525
Homepage URL
Email	sakiahs@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University, School of Medicine, College of Nursing, Department of Gerontological Nursing
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hitachikoh Hospital
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	日立港病院および横浜市立大学医学部看護学科 (Hitachikoh Hospital and Yokohama City University, School of Medicine, College of Nursing)

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 26 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	Completed
Date of protocol fixation	2014 Year 08 Month 18 Day
Date of IRB	2014 Year 08 Month 20 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 26 Day
Last modified on	2021 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017742