UMIN-CTR Clinical Trial

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

aspiration pneumonia

Classification by specialty

Medicine in general

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

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

Email

Institute

Kitano Hospital, The Tazuke Kofukai Medical Research Institute

Institute

Department

Personal name

Organization

The Tazuke Kofukai Medical Research Institute

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Nishi Kyoto Hospital
Intensive Care Home for the Elderly ,Yorokobien

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

11

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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