UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of effects of a new concentrated liquid diet on gastrointestinal symptoms during the nutritional management after maxillofacial surgery.
Title of the study (Brief title)	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	Kiyoshi Harada
Organization	Tokyo medical and dental university (gudaduate school)
Division name	maxillofacial surgery
Address	1-5-45 Yushima Bunkyo-ku, Tokyo
TEL	03-5803-5498
Email	haradak.mfs@tmd.ac.jp

Public contact
Name of contact person	Yoshio Ohyama
Organization	Tokyo medical and dental university (gudaduate school)
Division name	maxillofacial surgery
Address	1-5-45 Yushima Bunkyo-ku, Tokyo
TEL	03-5803-5500
Homepage URL
Email	yohyama.mfs@tmd.ac.jp

Sponsor
Institute	Tokyo medical and dental university (gudaduate school)
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015047