Clinical Trial: A Study on the Efficacy of Bridge Dry Swallowing for Gastroesophageal Reflux Disease: Randomised controlled trial (Japan)

Tokyo, Nov. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059650) titled 'A Study on the Efficacy of Bridge Dry Swallowing for Gastroesophageal Reflux Disease' on Nov. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Gifu University

Condition: Condition - Gastroesophageal reflux Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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

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 Size - 48

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067518

Disclaimer: Curated by HT Syndication.