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Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease

NCT05561179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-01-27

No results posted yet for this study

Summary

Gastroesophageal reflux disease (GERD) remains one of the most common pathologies seen among gastroenterologists, surgeons, and primary care physicians. The high prevalence of this condition lead to further investigations in its prevention, diagnosis, and management. For the treatment of this chronic condition, improvement in quality of life and long-term durability should be considered.

Nowadays, proton pump inhibitors (PPIs) are considered the mainstay in the treatment of the patients with GERD; however, due to the increasing concern related to its safety in its long-term use and the over prescription of these drugs, new surgical and endoscopic interventions have emerged.

A local treatment based on injections of hyaluronic acid, a natural nonimmunogenic mucosal defense, in the lower esophageal mucosa is a tentative treatment option for these patients. Based on this, the investigators pursue to assess the effects of hyaluronic acid in gastroesophageal reflux control.

Conditions

  • Gastroesophageal Reflux

Interventions

PROCEDURE

Hyaluronic acid injection

Patients with confirmed diagnosis of GERD will be treated with HA injections in the lower esophageal portion. HA + contrast will be injected in the 4 quadrants (4 cc/quadrant). The response to the treatment will be measured by improvement in health-related quality of life index, pH monitoring, and endoluminal functional lumen imaging probe (EndoFLIP). In addition, the patients will be clinically assessed for reflux symptoms.

PROCEDURE

Sodium chloride injection (control group)

Patients with a confirmed diagnosis of GERD will be treated with sodium chloride injection in the lower esophageal portion. Sodium chloride + contrast will be injected in the 4 quadrants (4 cc/quadrant). The response to the treatment will be measured by improvement in health-related quality of life index, pH monitoring, and endoluminal functional lumen imaging probe (EndoFLIP). In addition, the patients will be clinically assessed for reflux symptoms.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda, MD FASGE · Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-05-30
Completion
2023-09-30

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561179 on ClinicalTrials.gov