UMIN-CTR Clinical Trial

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
Email	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
Email	t.kanemitsu93@gmail.com

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053713