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Alginate vs Sucralfate for GERD Symptomatic Relief

Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07310927
Enrollment
140
Registered
2025-12-30
Start date
2025-04-01
Completion date
2026-04-01
Last updated
2026-03-19

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

Conditions

GERD

Brief summary

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.

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.

Interventions

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

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

Sponsors

CMH Lahore Medical College and Institute of Dentistry
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life in Reflux and DyspepsiaBefore Treatment, At 4 weeks, At 6 WeeksThis 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

MeasureTime frameDescription
Adverse Effects and TolerabilityBefore Treatment, At 2 weeks, At 4 WeeksUsing Structured AE Forms and A 5-Point Tolerability Scale
Gerd Symptom SeverityBefore Treatment, At 2 weeks, At 4 WeeksUsing 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.
Quality of Life (QOLRAD)Before Treatment, At 2 weeks, At 4 WeeksUsing 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.

Countries

Pakistan

Contacts

CONTACTMuhammad N Nasir, MBBS
nabeelnasir2004@live.com00923454500293
CONTACTMuhammad Hafeez
00923338555260
STUDY_CHAIRMuhammad Hafeez, MBBS

CMH Lahore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026