Alginate vs Sucralfate for GERD Symptomatic Relief

July 14, 2026 updated by: CMH Lahore Medical College and Institute of Dentistry

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Muhammad Hafeez
  • Phone Number: 00923338555260

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54180
        • CMH Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before Treatment, At 4 weeks, At 6 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Effects and Tolerability
Time Frame: Before Treatment, At 2 weeks, At 4 Weeks
Using Structured AE Forms and A 5-Point Tolerability Scale
Before Treatment, At 2 weeks, At 4 Weeks
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.
Before Treatment, At 2 weeks, At 4 Weeks
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.
Before Treatment, At 2 weeks, At 4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CMH Lahore Medical College and Institute of Dentistry

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Muhammad Hafeez, MBBS, CMH Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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