UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047090 |
|---|---|
| Receipt number | R000053713 |
| Scientific Title | Endoscopic Findings of Duodenal Mucosa after Fat Emulsified Food Loading |
| Date of disclosure of the study information | 2022/03/05 |
| Last modified on | 2022/05/10 20:35:20 |
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Basic information
Public title
Endoscopic Findings of Duodenal Mucosa after Fat Emulsified Food Loading
Acronym
Functional IEE study
Scientific Title
Endoscopic Findings of Duodenal Mucosa after Fat Emulsified Food Loading
Scientific Title:Acronym
Functional IEE study
Region
| Japan |
Condition
Condition
Patients with impaired fat absorption, or those with diarrhea, fatty stools, weight loss, anemia, etc., and suspected of having impaired fat absorption.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the endoscopic findings of the duodenal mucosa characteristic of gastrointestinal diseases with impaired fat absorption after loading with fat emulsified foods.
Basic objectives2
Others
Basic objectives -Others
stomach
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the endoscopic findings of the duodenal mucosa characteristic of gastrointestinal diseases with impaired fat absorption observed after fat emulsified food loading.
Key secondary outcomes
1) To determine the morphological characteristics of WOS-positive and WOS-negative duodenal mucosa observed by NBI magnification endoscopy after fat emulsified food loading will be determined.
2) To determine the pathological characteristics of WOS-positive and WOS-negative duodenal mucosa observed by NBI magnifying endoscopy after fatty emulsified food loading. 3) To determine the pathological characteristics of WOS-positive and WOS-negative duodenal mucosa observed by NBI magnifying endoscopy after fatty emulsified food loading.
3. to determine the characteristics of endoscopic findings of gastric mucosa (non-white light magnification, non-NBI magnification, and magnification with NBI) observed after fat emulsified food loading.
4) Determine the characteristics of endoscopic findings (non-magnified white light, non-magnified NBI, magnified NBI) of esophageal Barrett's epithelium observed after fat emulsified food loading.
5) To determine the relationship between the characteristics of the above endoscopic findings and the clinicopathological characteristics of the target patients.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
Patients will be given fat emulsified food 4 hours prior to the test day. Fat emulsified foods to be consumed are listed below.
Lotte "Sou" 190ml
(Ingredients)
Sugar (manufactured outside Japan, manufactured in Japan), vegetable oils and fats, dairy products, fructose, egg yolks (including eggs), foods made mainly from milk, dextrin, salt/emulsifier, stabilizer (polysaccharide thickener), flavor, annatto color
(Composition)
Energy 230kcal Protein 3.2g Fat 11.6g Carbohydrate 28.4g
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with any kind of gastrointestinal disease that requires upper gastrointestinal endoscopy.
2) Patients over 20 years old.
3) Patients who are able to consume fat emulsified food.
4) Patients who have given written consent to participate in the study.
Key exclusion criteria
1) Patients at high risk of bleeding during biopsy due to antithrombotic, anticoagulant, or antiplatelet medication.
2) Patients at high risk of bleeding from biopsy due to underlying diseases such as hepatic insufficiency, renal insufficiency, or blood coagulation abnormalities.
3) Patients with a history of gastrectomy.
4) Patients with lactose intolerance.
5) Other patients who are judged inappropriate for this study by the investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino City, Fukuoka
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kanemitsu |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino City, Fukuoka
TEL
092-921-1011
Homepage URL
t.kanemitsu93@gmail.com
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi 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
The ethics committee of Fukuoka University
Address
7-45-1, Nanakuma, Jonan Ward, Fukuoka City, Fukuoka
Tel
092-801-1011
fumed-ethics@fukuoka-u.ac.jp
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
福岡大学筑紫病院 (福岡)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053713
