A 12-month single-center, single-arm comparative study on the efficacy and safety of esophageal rehabilitation for acid suppressive medication-resistant gastroesophageal reflux disease

UMIN ID: UMIN000055920

Registered date:23/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastroesophageal reflux disease
• Date of first enrollment: 2024/10/23
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Swallowing training will be conducted 10 times at 7 to 10 seconds intervals in a supine position with their lower back raised. The program is performed twice a day for 12 months.

Outcome(s)

• Primary Outcome: The numerical value change of FSSG (Frequency Scale for the Symptoms of GERD) after 12 months' esophageal exercise therapy.
• Secondary Outcome: Changes in FSSG 2-4 weeks, 3 months, and 2 years after starting exercise therapy. Changes in acid suppressive medication intake and endoscopic mucosal lesions 2-4 weeks, 3 months, 1 year, and 2 years after starting exercise therapy. For those who gain consent, pH monitoring (24-hour esophageal pH monitoring or 24-hour esophageal impedance/pH monitoring) and manometry findings.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: Difficulty evaluating their own condition because of dementia or mental disturbance. Heart or respiratory failure, spinal disease or other poor general condition. Pregnant women or women who may be pregnant. Those who are under the control of a randomized study regarding gastroesophageal reflux disease. Those who are deemed inappropriate by their attending physician.

Related Information

• Primary Sponsor: Nishijin Hpspital
• Source(s) of Monetary Support: Self-Funding