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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055920
Enrollment
15
Registered
2024-10-23
Start date
2024-10-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux disease

Interventions

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.

Sponsors

Nishijin Hpspital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with GERD, whose symptom is refractory to conventional therapy including proton-pump inhibitor or vonoprazan and exhibit its FSSG score beyond 7. Participants will be registered six years after the date of approval of this study. Informed consent is obtained from all subjects before enrollment in the study.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
The numerical value change of FSSG (Frequency Scale for the Symptoms of GERD) after 12 months' esophageal exercise therapy.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactTomoko Nishimura

Nishijin Hospital Department of Internal Medicine

tnishimura@nishijinhp.com0754618800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026