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Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis

Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis - Reflux Symptom Development After Discontinuation of Acid suppressors in Reflux-Esophagitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029957
Enrollment
150
Registered
2018-01-15
Start date
2018-01-15
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

reflux esophagitis

Interventions

Intervention: For measurement of blood gastrin, blood H. pylori antibody, blood pepsinogen, 3 ml of blood is collected from subjects registered before drug withdrawal. Also, ask the subject to fill ou
s diary for symptomatic investigation to the subject, and ask the subject to fill in before bedtime everyday. Symptoms brought during visit 4 weeks after the questionnaire and symptom diary were colle
s background in the questionnaire and keeps it with the symptom questionnaire (GSRS, FSSG, HADS). Participating facilities other than our university will send blood specimens and survey forms to the s

Sponsors

Osaka Medical College
Lead Sponsor
Osaka Medical college Mishima Minami Hospital, Hirata city Hospital, Hokusetsu General Hospital, Daiichi Towakai Kai Hospital, Ishikiri-Seiki Hospital, Shitenno-ji Hospital, Aoyama Hospital, Hanwa Sumiyoshi General Hospital, Shiroyama Hospital, Seikeikai Hospital, Tatsumi Hospital, Sousei Hospital, Taisho Hospital, Keijinkai Moriguchi Hospital, Katsuragi Hospital, Midorigaoka Hospital, Osaka Kaisei Hospital, Kashiba-seiki Hospital, Rakusai Shimizu Hospital, Otowa Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Reflux esophagitis of LA grade A or B. (2) Patients undergoing treatment for more than 1 month at maintenance therapy for reflux esophagitis of Acid inhibitors (H2 receptor antagonist, proton pump inhibitor, potassium competitive acid blocker). (3) Patient with FSSG total score less than 8 points. (4) aged 20 years or older. Gender does not matter (5) Patients agreeing to participate in this study

Exclusion criteria

Exclusion criteria: 1.Refractory reflux esophagitis which resistant treatment for more than 4 weeks with PPI or P-cab 2.Patients with peptic ulcer 3.Patients in need of treatment due to functional dyspepsia, irritable bowel syndrome, inflammatory bowel disease complicated. 4.Patients with Zollinger-Ellison syndrome, advanced atrophic gastritis (Kimura Takemoto classification: O3) or malignant anemia. 5.Patients with a history of upper gastrointestinal resection or vagotomy. 6.Patients with warning findings such as vomiting, gastrointestinal bleeding (including findings of hematemesis, venous drainage, anemia, etc.), suddenly weight loss. 7.Patients with malignant finding confirmed or suspected 8.Patients in need of treatment (PPI, P-cab, H2RA, Gastrointestinal motility drug including Rikkunshito, Anticholinergic, Antidepressant, anxiolytic, Steroid excluding external preparations , Regular use of NSAID, aspirin preparation including low dose aspirin, bisphosphonate, calcium RA) during the study period. 9.Patients complicated with severe liver disease, kidney disease, heart disease etc. 10.Other patients who are considered inappropriate for study by investigaters

Design outcomes

Primary

MeasureTime frame
Investigate the correlation between FSSG total score change and H. pylori infection, pepsinogen I / II ratio, bloody gastrin value, sex, age, BMI, smoking, esophageal hiatal hernia.

Secondary

MeasureTime frame
Number of days to symptom onset. (symptoms diary) Investigate factors on affecting GSRS score including subscale, FSSG (reflux, motility) score, and HADS (depression) score value of change exploratory.

Countries

Japan

Contacts

Public ContactToshihisa Takeuchi

Osaka Medical College Endoscopy Center

in2097@osaka-med.ac.jp072-683-1221

Outcome results

None listed

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