Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease

Instituto Ecuatoriano de Enfermedades Digestivas

Status: Enrolling

Conditions: Gastroesophageal Reflux

Treatments: Procedure: Hyaluronic acid injection; Procedure: Sodium chloride injection (control group)

Study type: Interventional

Funder types: Other

Identifiers

NCT05561179

IECED-09282022

Details and patient eligibility

About

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.

Full description

GERD is one of the most common digestive pathologies, with a prevalence between 20% and 40% of adults. For the treatment of the disease, proton pump inhibitors (PPIs) have undoubtedly shown effective results; however, in around 30% of patients the complete resolution of symptoms fails.

For the latter, new therapeutic options should be considered. As a modern well-tolerated approach, and for local treatment, hyaluronic acid (HA) appeared to be an option for symptoms relief. HA is a glycosaminoglycan that acts as a natural defense for esophageal mucosa, able to organize the reticular structure as a filter to prevent the diffusion of high molecular substances. In addition, one of its remarkable features is the induction and control of epithelial cells turnover improving the re-epithelization process and the ulcer healing. In addition, hyaluronic acid compounds have shown no migration from the injection site in up to a three-year period.

Based on the above, the investigators aim to assess the effectiveness of hyaluronic acid in gastroesophageal reflux control, to considered it as an alternative effective treatment.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults >18 years old
• Patients with diagnosis of GERD (distal esophageal acid exposure time > 6% on 24hour ambulatory pH-impedance monitoring)
• Patients with abnormal distal esophageal acid exposure time (4%-6%) on 24-hour ambulatory pH-impedance monitoring
• Patients who authorized for endoscopic approach.

Exclusion criteria

• Pregnancy
• Any clinical condition which makes endoscopy inviable.
• Patients with severe anatomic conditions such as esophageal strictures, Barret´s esophagus, hiatal hernias.
• Previous esophageal surgery.
• Patients with a history of upper gastrointestinal neoplasia.
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

GERD + HA injections

Experimental group

Description:

This group is comprised by patients with GERD, assessed previously through 24-Hour pH impedance test and esophageal manometry. The patients are submitted to HA injections at the lower esophageal level.

Treatment:

Procedure: Hyaluronic acid injection

GERD without HA injections

Placebo Comparator group

Description:

This group is comprised by patients with GERD assessed previously through 24-Hour pH impedance test and esophageal manometry. The patients are submitted to sodium chloride at the lower esophageal level.

Treatment:

Procedure: Sodium chloride injection (control group)