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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016939
Receipt No. R000019554
Scientific Title The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy
Date of disclosure of the study information 2015/04/01
Last modified on 2016/05/03

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Basic information
Public title The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy
Acronym The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy
Scientific Title The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy
Scientific Title:Acronym The Study for the Difference in Gastric Motility between Elemental Diet (Elental) and Oligomeric Formula (Twinline) in the Patients Performed Percutaneous Endoscopic Gastrostomy
Region
Japan

Condition
Condition Dysphasia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In the patients who were performed percutaneous endoscopic gastrostomy, we investigate the difference in gastric motility between elemental diet (Elental) and oligomeric formula (Twinline).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gastric motility examined by ultrasonography (US) after feeding

1) Gastric emptying rate (GER):

GER = [(pyloric antral area (PA) at 1 minute after the end of feeding - PA at 15 minutes after the end of feeding) / PA at 1 minute after the end of feeding] * 100 (%)

We measure the PA by positioning the US probe vertically simultaneously visualized the antrum, superior mesenteric artery, and abdominal aorta.

2) Antral contraction:

Motility Index (MI) = Frequency * Amplitude

Frequency = the number of contractions per 3 minutes

Amplitude = [(PA at the time of relaxation - PA at the time of contraction) / PA at the time of relaxation] * 100 (%)

We calculate MI in 2-5 minutes after the end of feeding.
Key secondary outcomes Change in blood glucose levels (BG):

The difference between BG before feeding and 30 minutes after the end of feeding

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria In this study, we include the patients who are admitted to our hospital for periodic replacement of gastrostomy catheters under total enteral nutrition.
Key exclusion criteria We exclude the patients who have any of the following items.

1) vomiting

2) diarrhea (frequency of mushy or watery stool is 3 times a day or more)

3) fever (body temperature is higher than 37.5 degree centigrade)

4) hypoxemia (oxygen saturation measured on room air is less than 92%)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusaku Kajihara
Organization Fuyoukai Murakami Hospital
Division name Department of Gastroenterology
Zip code
Address 3-3-14 Hamada, Aomori 030-0843, Japan
TEL +81-17-729-8888
Email yukajihara-gi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusaku Kajihara
Organization Fuyoukai Murakami Hospital
Division name Department of Gastroenterology
Zip code
Address 3-3-14 Hamada, Aomori 030-0843, Japan
TEL +81-17-729-8888
Homepage URL
Email yukajihara-gi@umin.ac.jp

Sponsor
Institute Fuyoukai Murakami Hospital
Institute
Department

Funding Source
Organization Fuyoukai Murakami Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2015 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information On admission, we confirm that there are no problems affecting gastric motility in esophagogastroduodenoscopy for the replacement of gastrostomy catheter.

We feed in the early morning after overnight fasting on the 2nd and 3rd hospital day, and examine gastric motility by using a SSA-660A Xario US system (Toshiba, Japan) with a 3.5-MHz convex array transducer. Furthermore, we investigate the change in BG which can relate to gastric emptying.

We number all subjects in turns, and administer Elental (300 mL) on the 2nd hospital day and Twinline (300 mL) on the 3rd hospital day to the patients with odd numbers (administer Twinline (300 mL) on the 2nd hospital day and Elental (300 mL) on the 3rd hospital day to the patients with even numbers). The rate of administration is 250 mL per hour.

We conduct all statistical analyses using EZR (easy R) version 1.23 and consider a p value of <0.05 to be statistically significant. We use the Shapiro-Wilk test for normality and the F test for variance; we also use the two-sided paired t-test or two-sided Wilcoxon signed rank test for the difference between Elental and Twinline.

Management information
Registered date
2015 Year 03 Month 27 Day
Last modified on
2016 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019554

Research Plan
Registered date File name
2015/04/05 研究計画書(臨床研究へのご協力に関する説明文書を含む).docx

Research case data specifications
Registered date File name
2015/04/05 研究症例データ仕様書.xlsx

Research case data
Registered date File name
2015/03/29 データ一覧.xlsx


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