UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006732 |
|---|---|
| Receipt number | R000007952 |
| Scientific Title | The effects of PEG tube feeding of semi-solid nutrients on salivation |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2011/11/15 17:37:36 |
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Basic information
Public title
The effects of PEG tube feeding of semi-solid nutrients on salivation
Acronym
The effects of PEG tube feeding of semi-solid nutrients on salivation
Scientific Title
The effects of PEG tube feeding of semi-solid nutrients on salivation
Scientific Title:Acronym
The effects of PEG tube feeding of semi-solid nutrients on salivation
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of liquid or semi-solid enteral nutrition on salivation and oral environments of patients with percutaneous endoscopic gastrostomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the change of salivary secretion after administration of liquid or semi-solid enteral nurtients
Key secondary outcomes
To measure pH of saliva and to evaluate status of gastroesophageal reflux
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of liquid nutrients for 7 days followed by semi-solid nutrients for 7 days
Interventions/Control_2
Administration of semi-solid nutrients for 7 days followed by solid nutrients for 7 days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)At least 2 weeks have passed after gastrostomy.
(2)Patients required tube-feeding in hospital setting
(3)Patients with correctable dehydration by the time of enrollment if they have.
(4)Patients over 20 years-old and who have given written informed consent by themselves or their representative
(5)Regardless of gender
Key exclusion criteria
(1) Patients with diseases that affect salivation such as Sjogren's syndrome, sialoadenitis, salivary gland cancer
(2) Patients with remarkably decreased salivation(patients with less than 0.05g in 30 seconds assessed by the cotton methods)
(3) Patients with severe infection of gastrostomy site
(4) Patients with active aspiration pneumonitis
(5) Patients who can take food orally
(6) Patients with ileus or no residual intestinal function
(7) Patients who have not undergone neither oral feeding nor tube feeding over 30 days
(8) Patients with severe liver disorder(AST or ALT 2.5 times higher than upper normal limit of the institution)
(9) Patients with poor control of diabetes mellitus(HbA1C > 8.0%)
(10) Patients with renal dysfunction(Cre > 2.0mg/dl)
(11) Patients with allergy to any ingredients of the enteral formula
(12) Patients who were judged as inappropriate to enroll clinical study by physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motonari Fukui,M.D.,Ph.D. |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Respiratory Disease Center
Zip code
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Ishitoko,M.D. |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Respiratory Disease Center
Zip code
Address
2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
The Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nishi Kyoto Hospital
Intensive Care Home for the Elderly ,Yorokobien
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 15 | Day |
Last modified on
| 2011 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007952
