UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059650 |
|---|---|
| Receipt number | R000067518 |
| Scientific Title | A Study on the Efficacy of Bridge Dry Swallowing for Gastroesophageal Reflux Disease: Randomised controlled trial |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 17:24:37 |
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Basic information
Public title
A Study on the Efficacy of Bridge Dry Swallowing for Gastroesophageal Reflux Disease
Acronym
Bridge Dry Swallowing for Gastroesophageal Reflux Disease
Scientific Title
A Study on the Efficacy of Bridge Dry Swallowing for Gastroesophageal Reflux Disease: Randomised controlled trial
Scientific Title:Acronym
BRIDGE Trial
Region
| Japan |
Condition
Condition
Gastroesophageal reflux
Classification by specialty
| Gastroenterology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate whether a defined period of bridge dry swallowing training, performed in an anti-gravity (hip-raised) position, leads to improvement of symptoms in patients with mild gastroesophageal reflux disease (GERD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FSSG (Frequency Scale for the Symptoms of GERD) questionnaire at 4-week follow-up
Key secondary outcomes
Upper Gastrointestinal Endoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to lifestyle guidance, participants will perform dry swallowing in the anti-gravity esophageal position (bridge position) 10 times per day for 4 weeks.
Interventions/Control_2
Lifestyle guidance
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
Patients with GERD symptoms and an FSSG (Frequency Scale for the Symptoms of GERD) score of more than 8.
Outpatients or inpatients in whom diseases other than GERD have been ruled out by EGD (esophagogastroduodenoscopy).
Patients with preserved cognitive function sufficient to fully understand the study outline and training procedure.
Patients who have provided written informed consent.
Key exclusion criteria
Patients who have difficulty assuming the bridge (hip-raised) position due to low back pain or other conditions.
Patients with severe dysphagia who are unable to swallow saliva.
Pregnant women or those who may be pregnant.
Patients with Los Angeles classification grade C or D esophagitis.
Patients taking acid-suppressing medications (PPI, P-CAB, H2-receptor antagonists), mosapride, rikkunshito, or aluminum hydroxide gel at the time of consent.
Patients with severe hiatal hernia who are considered to be at high risk of aspiration pneumonia due to regurgitation or vomiting.
Any other patients deemed inappropriate for inclusion by the principal investigator or subinvestigators.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Aoyama |
Organization
Chikamori Rehabilitation Hospital
Division name
Rehabilitation Medicine
Zip code
780-0843
Address
2-22, Nijudaimachi, Kochi-shi, Kochi 780-0843, Japan
TEL
088-822-5231
keiaoyama1209@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenjiro |
| Middle name | |
| Last name | Kunieda |
Organization
Gifu University, Graduate School of Medicine
Division name
Department of Neurology
Zip code
501-1194
Address
1-1, Yanagido, Gifu-shi, Gifu
TEL
0582306254
Homepage URL
ken2rou.k@gmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Kenjiro Kunieda
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Neurology, Graduate School of Medicine
Address
1-1, Yanagido, Gifu-City, Gifu
Tel
0582306254
ken2rou.k@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
岐阜県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | 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
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067518
