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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035427
Receipt No. R000040360
Scientific Title Effects of enteral nutrition on intestinal flora of patients with PPI -A prospective observational study in stroke patients-
Date of disclosure of the study information 2019/01/03
Last modified on 2019/01/03

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Basic information
Public title Effects of enteral nutrition on intestinal flora of patients with PPI -A prospective observational study in stroke patients-
Acronym Intestinal flora and enteral nutrition with PPI
Scientific Title Effects of enteral nutrition on intestinal flora of patients with PPI -A prospective observational study in stroke patients-
Scientific Title:Acronym Intestinal flora and enteral nutrition with PPI
Region
Japan

Condition
Condition Stroke patients
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the effect of enetral nutrition on intestinal flora of patients with PPI.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of Clostridium in the intestinal microflora after 2 weeks
Key secondary outcomes Oraganic acids
pH value of feces

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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Receive enteral tube feeding for 2weeks or more after admission
2) Receive PPI for 2weeks or more after admission
Key exclusion criteria 1) Regularly use PPI before admission
2) Allergy to soybean,gelatin,milk components
3) AST>80U/L or AST>80U/L
4) HbA1c>8.0%
5) Cre>2.0mg/dL or BUN>44mg/dL
6) Short bowel syndrome
7) Receive chemotherapy or radiotherapy
8) Inability to give informed consent form
9) Judged by the investigators to be inappropriate participants in this study
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Haruki Takahashi
Organization Obase Hospital
Division name Neurosurgery
Zip code
Address 1598 Aratsu, Kanda-machi, Miyako-gun, Fukuoka, Japan
TEL 0930-24-5211
Email haruki.ta@youmeikai.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Haruki Takahashi
Organization Obase Hospital
Division name Neurosurgery
Zip code
Address 1598 Aratsu, Kanda-machi, Miyako-gun, Fukuoka, Japan
TEL 0930-24-5211
Homepage URL
Email haruki.ta@youmeikai.jp

Sponsor
Institute Obase Hospital
Department of neurosurgery
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Factory
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
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 小波瀬病院(福岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 03 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study
The purpose of this study is to clarify the effect of enteral nutrition on intestinal flora of patients with PPI.

Management information
Registered date
2019 Year 01 Month 03 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040360

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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