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A study to compare whether there is a difference in the improvement of swallowing function between two types of anti-gastric ulcer drugs for elderly people with a history of gastric ulcer and dysphagia.

Prospective intervention study of swallowing function improvement anti-gastric ulcer drugs in the elderly.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1021230018
Enrollment
88
Registered
2023-07-29
Start date
2023-07-29
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

Swallowing dysfunction Gastric ulcer Swallowing dysfunction, Elderly People

Interventions

Institutional elderly people aged 65 and over with a history of gastric ulcer who have dysphagia are divided into two groups, and each group received 150 mg/day of polaprezinc tablet or 300 mg/day of

Sponsors

Seki Yumika
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Elderly people aged 65 years or older with a history of gastric ulcer who have subjective symptoms of swallowing dysfunction or who have been diagnosed with swallowing dysfunction, and who are taking antacids.

Exclusion criteria

Exclusion criteria: 1.Difficult to take gastric ulcer drugs due to severe dementia or deterioration of consciousness. 2.Patients with a history of limb amputation near the wrist or ankle. 3.Continuously taking test drugs (polaprezinc, rebamipide) for more than 1 week within 2 weeks before informed consent. 4.Have been hospitalized for more than 1 week within 2 weeks before informed consent. 5.Patients who are judged to be unsuitable to participate in this study by the principal investigator or co-investigator. 6.Patients who are allergic to test drugs (polaprezinc, rebamipide) . 7.Patients who are judged to be difficult to participate in the study due to complication of psychosis or psychiatric symptoms. 8.Patients who are judged to be unable to perform the test due to severe dementia, etc.

Design outcomes

Primary

MeasureTime frame
Improvement of swallowing reflex induction rate by taking a zinc-containing gastric ulcer drug or a non-zinc-containing gastric ulcer drug.

Secondary

MeasureTime frame
1. Including cases that dropped out without performing 3 measurements of the simple swallowing provocation test, comparison of the amount of change in swallowing reflex induction time. 2.Comparison of the number of cases with improved swallowing reflex induction time. 3. Improvement of ADL and sarcopenia, gait status, score, and muscle mass. 4. Improvement of nutritional items in blood and biochemical tests. 5. Difference in increase in serum zinc concentration due to concomitant drugs, difference in the number of people who improved. 6. Difference in serum zinc concentration increase due to comorbidities, difference in the number of people who improved. 7. Changes in serum zinc concentration and substance P in blood and saliva. 8. Confirmation of the safety of administration of two gastric ulcer drugs to patients with dysphagia.

Contacts

Public ContactYumika Seki

Iwate Prefectural Central Hospital

seki.yumika.r7@dc.tohoku.ac.jp+81-19-653-1151

Outcome results

None listed

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