UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of gastroesophageal reflux in patients without reflux symptoms
Acronym	Assessment of gastroesophageal reflux in non-GERD patients
Scientific Title	Assessment of gastroesophageal reflux in patients without reflux symptoms
Scientific Title:Acronym	Assessment of gastroesophageal reflux in non-GERD patients
Region	Japan

Condition
Condition	Gastroesophageal reflux disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess motility and reflux in patients without reflux symptoms using esophageal high-resolution impedance manometry (HRIM) and multiple intraluminal impedance-pH (MII-pH)
Basic objectives2	Others
Basic objectives -Others	To assess postprandial motility and reflux in patients without reflux symptoms using esophageal HRIM
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Esophageal acid exposure in MII-pH
Key secondary outcomes	1. Total reflux episodes including acid and non-acid in MII-pH 2. Total supragastric belching (SGB) episodes in MII-pH 3. Transient lower esophageal sphincter relaxation (TLESR) episodes in a postprandial period in HRIM 4. TLESR with reflux episodes in a postprandial period in HRIM 5. Postprandial SGB episodes in MII-pH 6. Postprandial rumination episodes in HRIM

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Esophageal high-resolution impedance manometry for one hour and multiple intraluminal impedance-pH monitoring for 24hours
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Participants aged between 20-70 years of either gender without reflux symptoms (2)Performance Status (ECOG): 0-1 (3)Ability to understand the study information sheet and instructions and able to provide informed consent.
Key exclusion criteria	(1) Taking NSAIDs, steroids, immunosuppresive medications (2) Prior abdominal surgery (3) Prior chemotherapy (4) Diabetes and collagen disease (5) Taking acid suppressive medications and prokinetics (6) Prior allergic reaction to Xylocain (7) Difficulty in inserting a catheter due to narrow nasal cavity
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Koike
Organization	Tohoku university
Division name	Gastroenterology
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
TEL	022-717-7171
Email	tkoike@rd5.so-net.ne.jp

Public contact
Name of contact person	1st name Kenichiro Middle name Last name Nakagawa
Organization	Tohoku Univerisity
Division name	Gastroenterology
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
TEL	022-717-7171
Homepage URL
Email	k.nakagawa221@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics committee of Tohoku University
Address	1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
Tel	022-717-7000
Email	rinri-esct@proj.med.tohoku.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

Other administrative information
Date of disclosure of the study information	2021 Year 06 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 01 Day
Date of IRB	2021 Year 06 Month 22 Day
Anticipated trial start date	2021 Year 06 Month 22 Day
Last follow-up date	2026 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	2021 Year 04 Month 17 Day
Last modified on	2022 Year 10 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050205