ALSUC in refractory GERD

The Effect of capsules containing sucralfate/sodium alginate in patients with refractory gastroesophageal reflux disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211203053263N3

Enrollment

656

Registered

2024-05-09

Start date

2024-03-15

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

GERD. Gastro-esophageal reflux disease

Interventions

Intervention 1: Intervention group: patients will receive cap ALSUC containing 500 mg sucralfate and 500 mg sodium alginate after each meal and at bedtime for 8 weeks. Intervention 2: Control group:

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients who remained symptomatic (assessed by daily reflux questionnaire) with a standard dose of PPI after a trial period of treatment of at least 2 months.

Exclusion criteria

Exclusion criteria: non-compliant inappropriate use of PPI Other diseases that can mimic the symptoms of GERD include achalasia, eosinophilic esophagitis, infectious esophagitis, pill esophagitis, gastroparesis, severe erosive GERD (Los Angeles classification grades C–D), Barrett’s esophagus, esophageal stricture or cancer. H. pylori infection diabetes mellitus advanced kidney impairment

Design outcomes

Primary

Measure	Time frame
Percentage of complete heartburn-free days. Timepoint: During intervention. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Percentage of complete regurgitation-free days. Timepoint: During intervention. Method of measurement: Questionnaire.;Changes from baseline to week 8 in weekly heartburn severity score. Timepoint: During intervention. Method of measurement: Questionnaire.;Changes from baseline to week 8 in weekly regurgitation severity score. Timepoint: During intervention. Method of measurement: Questionnaire.;Percentage of days without rescue antacid use over the treatment period. Timepoint: During intervention. Method of measurement: Questionnaire.;Time up to the first 24/48 hours without heartburn. Timepoint: During intervention. Method of measurement: Questionnaire.;Time up to the first 24/48 hours without regurgitation. Timepoint: During intervention. Method of measurement: Questionnaire.;Proportion of patients with complete resolution of heartburn at week 8. Timepoint: week 8. Method of measurement: Questionnaire.;Proportion of patients with complete resolution of regurgitation at week 8. Timepoint: week 8. Method of measurement: Questionnaire.	—

Measure

Time frame

Percentage of complete regurgitation-free days. Timepoint: During intervention. Method of measurement: Questionnaire.;Changes from baseline to week 8 in weekly heartburn severity score. Timepoint: During intervention. Method of measurement: Questionnaire.;Changes from baseline to week 8 in weekly regurgitation severity score. Timepoint: During intervention. Method of measurement: Questionnaire.;Percentage of days without rescue antacid use over the treatment period. Timepoint: During intervention. Method of measurement: Questionnaire.;Time up to the first 24/48 hours without heartburn. Timepoint: During intervention. Method of measurement: Questionnaire.;Time up to the first 24/48 hours without regurgitation. Timepoint: During intervention. Method of measurement: Questionnaire.;Proportion of patients with complete resolution of heartburn at week 8. Timepoint: week 8. Method of measurement: Questionnaire.;Proportion of patients with complete resolution of regurgitation at week 8. Timepoint: week 8. Method of measurement: Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShaahin Shahbazi

Ilam University of Medical Sciences

mdkabe@gmail.com+98 21 8821 3960

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026