UMIN-CTR Clinical Trial

Public title

Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition

Acronym

Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition

Scientific Title

Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition

Scientific Title:Acronym

Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition

Region

Japan

Condition

Inpatients receiving enteral nutrition via nasogastric tube, gastric fistula, or intestinal fistula

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Cardiology	Pneumology	Endocrinology and Metabolism
Nephrology	Neurology	Clinical immunology
Surgery in general	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery
Chest surgery	Endocrine surgery	Oto-rhino-laryngology
Orthopedics	Urology	Neurosurgery
Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the preventive effect of the use of gastrointestinal nutrient pump on gastrointestinal complications.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

[BLOOD] labo data (on the registration, two weeks after, and at the end of the study)
Blood chemistry: TP, ALB, BUN, CRE, CHE, T-CHO, TG, Na, Cl, K, GLU
General blood count: WBC, RBC, Hb, Ht, SEG, LYMPH
[URINE] labo data (on the registration, two weeks after, and at the end of the study)
Specific gravity
[OBSERVATION] items
Defecation situation (with Bristol scale)
Weight and frequency of defecation

Key secondary outcomes

Frequency of abdominal pain, nausea, and vomiting
Presence of pressure ulcers, the presence of diaper rash, body weight, catheter problems, and choking

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Nutrition pump group

Interventions/Control_2

Naturally dropped group

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

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Inpatients aged from 20 to 90 years receiving enteral nutrition via nasogastric tube, gastric fistula, or intestinal fistula

Key exclusion criteria

1. CD toxin positive
2.Patient with diarrhea by antibiotic or other medicines such as laxative
3.Patient taking:
The semisolid preparation, K2-S, K-LEC, enteral nutrition containing more than 1.7 g/100 kcal of dietary fiber or 1 kcal/mL of calories.
4.Patient with impaired gastrointestinal absorption due to diseases (short bowel syndrome and inflammatory bowel disease)
5.Patient with impaired gastrointestinal motility due to disease
6.Patient with aspiration pneumonia
7. Severely ill patient with multiple (>2) organ failure
8.Patient with severe diarrhea
9.Patient with fatty diarrhea
10.Patient with lactose intolerance
11.Patient not recommended to be registered by physician

Target sample size

200

Name of lead principal investigator

1st name	Yuko
Middle name
Last name	Okuyama

Organization

Toho University Ohashi Medical Center

Division name

Pharmaceutical department

Zip code

1530085

Address

2-22-36 Ohashi, Meguro-ku Tokyo

TEL

03-3468-1251

Email

ph-youka@oha.toho-u.ac.jp

Name of contact person

1st name	Yuko
Middle name
Last name	Okuyama

Organization

Toho University Ohashi Medical Center

Division name

Pharmaceutical department

Zip code

1530085

Address

2-22-36 Ohashi, Meguro-ku Tokyo

TEL

03-3468-1251

Homepage URL

Email

ph-youka@oha.toho-u.ac.jp

Institute

Division of Clinical pharmacokinetics, Faculty of Pharmacy, Keio University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

The clover hospital
Nishigunma national hospital
Toho University Medical center Omori hospital
Showa University Fujigaoka hospital

Name of secondary funder(s)

Organization

Toho University Ohashi Medical Center

Address

2-22-36 Ohashi, Meguro-ku Tokyo

Tel

03-3468-1251

Email

secretary@oha.toho-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

クローバーホスピタル（神奈川県）、西群馬病院（群馬県）、東邦大学医療センター大森病院（東京都）、昭和大学藤が丘病院　（神奈川県）、東邦大学医療センター大橋病院（東京都）

Date of disclosure of the study information

2011

Year

05

Month

16

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

Open public recruiting

Date of protocol fixation

2011

Year

03

Month

02

Day

Date of IRB

Anticipated trial start date

2011

Year

05

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

05

Month

16

Day

Last modified on

2019

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006628