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Completed

NCT Number: NCT07310927

Alginate vs Sucralfate for GERD Symptomatic Relief

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cmh Lahore

Lahore, Punjab Province, 54180, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Alginate

Drug

2 Table spoon spoon suspension syrup twice a day before meal.

Other names: Gaviscon

Sucralfate

Drug

2 Table spoon spoon suspension syrup twice a day before meal.

Other names: Ulsanic

Primary outcomes

  1. Quality of Life in Reflux and Dyspepsia

    Time frame: Before Treatment, At 4 weeks, At 6 Weeks

    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.

Secondary outcomes

  1. Adverse Effects and Tolerability

    Time frame: Before Treatment, At 2 weeks, At 4 Weeks

    Using Structured AE Forms and A 5-Point Tolerability Scale

  2. Gerd Symptom Severity

    Time frame: Before Treatment, At 2 weeks, At 4 Weeks

    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.

  3. Quality of Life (QOLRAD)

    Time frame: Before Treatment, At 2 weeks, At 4 Weeks

    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.

Sponsors and collaborators

Lead sponsor

CMH Lahore Medical College and Institute of Dentistry

Other

Registry information

Official study title

Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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