UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035427 |
|---|---|
| Receipt number | 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 | 2023/07/10 12:52:40 |
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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
| 100 | 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) Allergy to soybean,gelatin,milk components
2) AST>80U/L or AST>80U/L
3) HbA1c>8.0%
4) Cre>2.0mg/dL or BUN>44mg/dL
5) Short bowel syndrome
6) Receive chemotherapy or radiotherapy
7) Inability to give informed consent form
8) Judged by the investigators to be inappropriate participants in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Takahashi |
Organization
Obase Hospital
Division name
Neurosurgery
Zip code
800-0344
Address
1598 Aratsu, Kanda-machi, Miyako-gun, Fukuoka, Japan
TEL
0930-24-5211
haruki.ta@youmeikai.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Takahashi |
Organization
Obase Hospital
Division name
Neurosurgery
Zip code
8000344
Address
1598 Aratsu, Kanda-machi, Miyako-gun, Fukuoka, Japan
TEL
0930-24-5211
Homepage URL
haruki.ta@youmeikai.jp
Sponsor or person
Institute
Obase Hospital
Department of neurosurgery
Institute
Department
Personal name
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
Hattori clinic
Address
2-12-8,Shinjyuku,Shinjyuku-ku,Tokyo,Japan
Tel
03-5919-2052
reception-office@hattori-irb.com
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040360
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040360
Number of participants that the trial has enrolled
26
Results
These results indicate that a dietary fiber-containing enteral nutrition plays a role in the control of C.difficile infection in patients using PPI and suggest that HE may maintain an environment with a low pH for the gut microbiota compared to PF.
Results date posted
| 2023 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We selected 26 patients with acute stroke, receiving intragastric tube feeding with PPI for at least two weeks.
Participant flow
They were non-randomized into two groups to receive either HE(12) or PF(14).
Adverse events
none
Outcome measures
The composition of the fecal microbiota and the concentration of short-chain fatty acids (SCFA) with fecal pH were evaluated using terminal restriction fragment length polymorphism(T-RFLP) analysis before and after enteral nutrition.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 20 | Day |
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
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040360
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