UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013012
Receipt number R000015047
Scientific Title Study of effects of a new concentrated liquid diet on gastrointestinal symptoms during the nutritional management after maxillofacial surgery.
Date of disclosure of the study information 2014/02/03
Last modified on 2019/02/13 23:49:59

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Basic information

Public title

Study of effects of a new concentrated liquid diet on gastrointestinal symptoms during the nutritional management after maxillofacial surgery.

Acronym

Clinical study of a new concentrated liquid diet.

Scientific Title

Study of effects of a new concentrated liquid diet on gastrointestinal symptoms during the nutritional management after maxillofacial surgery.

Scientific Title:Acronym

Clinical study of a new concentrated liquid diet.

Region

Japan


Condition

Condition

Patients undergoing oral surgery

Classification by specialty

Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of a novel liquid diet on gastrointestinal symptoms during the nutrition management after oral surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

An achievement rate of nutritional control
When all the following conditions are met, the nutritional control is defined to be "achieved."
- Ninety percent or more of the targeted amount of test diet was administered.
- The number of use of antiflatulents is two or smaller.
- The frequency of stool per day is three times or lower.
- Neither watery stool nor muddy stool was observed.

Key secondary outcomes

- Nutritional parameters (blood albumin, blood total protein, body weight)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

new concentrated liquid diet group
The test diet is administered from the surgery day through 3 days after surgery in the manner of three times a day (morning, around noon, and evening). The dose is adjusted from 1000 to 1800 kcal/day depending on the sex and body weight.

Interventions/Control_2

Control group (marketed liquid diet group)
The test diet is administered from the surgery day through 3 days after surgery in the manner of three times a day (morning, around noon, and evening). The dose is adjusted from 1000 to 1800 kcal/day depending on the sex and body weight.

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) Patients aged 20 years or older at the date of informed consent
2) Patients who plan to receive an oral surgery
3) Patients who are indicated to receive the trans-nasal nutrition as the postsurgical nutrition management
4) Patients who provide voluntary consent after receiving a sufficient oral and written explanation about the study

Key exclusion criteria

1) Patients who take or receive the drugs prohibited to use during the study period
2) Patients who have the disease history of gastroduodenal ulcer or other upper gastrointestinal diseases
3) Patients who might have food allergies or allergies to the products used in the study
4) Patients who receive anticancer drugs or radiotherapy
5) Patients who deemed to be unsuitable for inclusion in the study due to concomitant diseases including hepatic disorder, renal disorder, and cardiac disorder
6) Female patients who are pregnant, lactating, or potentially pregnant
7) Others who are deemed unsuitable for inclusion in the study for any other reason based on decision by the investigator

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoshi Harada

Organization

Tokyo medical and dental university (gudaduate school)

Division name

maxillofacial surgery

Zip code


Address

1-5-45 Yushima Bunkyo-ku, Tokyo

TEL

03-5803-5498

Email

haradak.mfs@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshio Ohyama

Organization

Tokyo medical and dental university (gudaduate school)

Division name

maxillofacial surgery

Zip code


Address

1-5-45 Yushima Bunkyo-ku, Tokyo

TEL

03-5803-5500

Homepage URL


Email

yohyama.mfs@tmd.ac.jp


Sponsor or person

Institute

Tokyo medical and dental university (gudaduate school)

Institute

Department

Personal name



Funding Source

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 03 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 20 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 30 Day

Last modified on

2019 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015047


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name