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
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
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
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
