Alginate vs Sucralfate for GERD Symptomatic Relief

Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS

Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus.It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Sucralfate is a unique anti-ulcer drug and is a basic aluminum salt of sucrose octa-sulfate. It forms a protective layer, enhancing bicarbonate production, demonstrating anti-peptic properties, and fostering tissue growth, regeneration, and repair and it undergoes minimal enteral reabsorption. Alginate is a naturally occurring anionic polymer typically obtained from brown seaweed and has been extensively investigated and used for many biomedical applications, due to its biocompatibility, low toxicity, relatively low cost, and mild gelation by addition of divalent cations such as Ca2+.Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations.

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: Alginate; Drug: Sucralfate

Detailed Description

Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus. It is one of the most commonly diagnosed digestive disorders in the young adult population with a prevalence of 20%. Clinically GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Several causative factors have been identified and implicated in the pathogenesis of GERD, like motor abnormalities such as esophageal dysmotility clearance, decrease tone of the lower esophageal sphincter (LES), transient LES relaxation, and delayed gastric emptying, and others are anatomical defects like hiatus hernia and obesity Sucralfate is a unique anti-ulcer drug and is a basic aluminum salt of sucrose octa-sulfate. It forms a protective layer, enhancing bicarbonate production, demonstrating anti-peptic properties, and fostering tissue growth, regeneration, and repair and it undergoes minimal enteral reabsorption. Alginate is a naturally occurring anionic polymer typically obtained from brown seaweed and has been extensively investigated and used for many biomedical applications, due to its biocompatibility, low toxicity, relatively low cost, and mild gelation by addition of divalent cations such as Ca2+.Alginate reacts with gastric acid, forming a gel-like raft that floats on the stomach contents. The raft acts as a physical barrier, preventing acid from reaching the esophagus. Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations. This randomized clinical trial will oversee the effects of alginates versus sucralfate for GERD symptomatic relief in combination with proton pump inhibitors.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54180
      • Cmh Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients having symptoms of severe GERD for more than 3 times /week

Exclusion Criteria:

1. Patients with preexisting cardiovascular disorders
2. Patients with chronic kidney or liver diseases
3. Patients with gross abnormalities on upper GI endoscopies e.g.; ulcers, tumors or those with history of upper GI surgery
4. Pregnant and breast feeding
5. Absence of Erosive esophagitis
6. Patients with peptic esophageal ulcers
7. PPI use within 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alginate Group; Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.	Drug: Alginate; 2 Table spoon spoon suspension syrup twice a day before meal.; Other Names: Gaviscon
Active Comparator: Sucralfate Group; Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.	Drug: Sucralfate; 2 Table spoon spoon suspension syrup twice a day before meal.; Other Names: Ulsanic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life in Reflux and Dyspepsia	This involves questionnaire related to the symptoms and impact on quality of life. The total score is 140, ranging from 0 to 140, the higher the score the worse will be the symptoms.	Before Treatment, At 4 weeks, At 6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Effects and Tolerability	Using Structured AE Forms and A 5-Point Tolerability Scale	Before Treatment, At 2 weeks, At 4 Weeks
Gerd Symptom Severity	Using the 0-4 GERD Symptom Severity Scale, total number of items 20. Total score is 80, ranging from 0 to 80, the higher the score the worse will be the symptoms.	Before Treatment, At 2 weeks, At 4 Weeks
Quality of Life (QOLRAD)	Using The Validated 0-4-Point Likert QOLRAD Questionnaire, total number of items is 15.Total score is 60, ranging from 0 to 60, the higher the score the worse will be the symptoms.	Before Treatment, At 2 weeks, At 4 Weeks

Collaborators and Investigators

• Sponsor: CMH Lahore Medical College and Institute of Dentistry
• Investigators: Study Chair: Muhammad Hafeez, MBBS, Cmh Lahore

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Sulfur Compounds; Organic Chemicals; Carbohydrates; Polysaccharides; Disaccharides; Oligosaccharides; Sugars; Thioglycosides; Sucrose; Sucralfate; Alginates; alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
• Other Study ID Numbers: 580/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No