weight loss diet with double dose proton pump inhibitor therapy and improving symptoms and endoscopic findings in patients with refractory reflux with abdominal obesity

Studying the effect of weight loss diet combined with double dose proton pump inhibitor therapy on improving symptoms and endoscopic findings in patients with refractory reflux and abdominal obesity: A randomized controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100530004055N1

Enrollment

Registered

2026-05-26

Start date

2026-05-20

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Gastro-esophageal reflux disease. Gastro-esophageal reflux disease with esophagitis

Interventions

Intervention 1: Intervention group: Will receive Weight loss diet along with a proton pump inhibitor for 8 weeks. Intervention 2: Control group: Will receive dietary recommendations along with a proto

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Willingness to cooperate and complete the informed consent form. Age > 18 years. Abdominal obesity Their symptoms have not responded to a standard dose of PPI therapy for at least two months. Patients who have experienced heartburn or regurgitation at least four times per week prior to the start of the study. Good compliance with treatment. Absence of Barrett’s esophagus. Absence of other conditions that may mimic gastroesophageal reflux symptoms (eosinophilic esophagitis, infectious esophagitis, pill-induced esophagitis).

Exclusion criteria

Exclusion criteria: Gastroparesis. Esophageal stricture or esophageal cancer. Helicobacter pylori infection. Advanced renal impairment. Unwillingness to continue participation during the study implementation. Change of treatment based on the physician’s decision.

Design outcomes

Primary

Measure	Time frame
Endoscopic changes. Timepoint: 4 weeks after completion of the intervention. Method of measurement: Endoscopy.	—

Secondary

Measure	Time frame
Percentage of heartburn-free days. Timepoint: Over the 8-week period. Method of measurement: Questionnaire.;Percentage of regurgitation-free days. Timepoint: Over the 8-week period. Method of measurement: Questionnaire.;Percentage of days without antacid use during the treatment period. Timepoint: Over the 8-week period. Method of measurement: Questionnaire.;=50% reduction in heartburn and regurgitation severity scores from baseline to week 8. Timepoint: At the end of the 8th week. Method of measurement: Questionnaire.;Percentage of patients with complete resolution of heartburn. Timepoint: At week 8. Method of measurement: Questionnaire.;Percentage of patients with complete resolution of regurgitation. Timepoint: At week 8. Method of measurement: Questionnaire.	—

Measure

Time frame

Percentage of heartburn-free days. Timepoint: Over the 8-week period. Method of measurement: Questionnaire.;Percentage of regurgitation-free days. Timepoint: Over the 8-week period. Method of measurement: Questionnaire.;Percentage of days without antacid use during the treatment period. Timepoint: Over the 8-week period. Method of measurement: Questionnaire.;=50% reduction in heartburn and regurgitation severity scores from baseline to week 8. Timepoint: At the end of the 8th week. Method of measurement: Questionnaire.;Percentage of patients with complete resolution of heartburn. Timepoint: At week 8. Method of measurement: Questionnaire.;Percentage of patients with complete resolution of regurgitation. Timepoint: At week 8. Method of measurement: Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Vahdat Shariatpanaahi

Shahid Beheshti University of Medical Sciences

nutritiondata@yahoo.com+98 21 2235 7484

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026