Clinical trial NCT05561179: Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
Official title: Hyaluronic Acid as a Novel Therapeutic Approach for Patients With GERD: a Single-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux
hyaluronic acid
Esophageal Sphincter
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A non-blinded, single center, randomized prospective trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acid exposure to the distal esophagus after intervention
timeFrame: Up to 6 months
measure: Assessment of esophageal transit and gastric emptying
timeFrame: Up to 1 month
measure: Change in health-related quality of life
timeFrame: up to 6 months
Secondary outcomes:
measure: Evaluation of lower esophageal sphincter (LES) distensibility and pressure by EndoFLIP
timeFrame: Up to 1 month
measure: Safety of HA injections in GERD
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
state: Guayas
Study officials:
affiliation: Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
name: Carlos Robles-Medranda, MD FASGE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katz PO, Dunbar KB, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022 Jan 1;117(1):27-56. doi: 10.14309/ajg.0000000000001538.
citation: Martin K, Emil S, Bernard C, Gaied F, Blumenkrantz M, Laberge JM, Morinville V, Nguyen VH. Dextranomer hyaluronic acid copolymer effects on gastroesophageal junction. J Pediatr Gastroenterol Nutr. 2014 May;58(5):593-7. doi: 10.1097/MPG.0000000000000259.
citation: Palmieri B, Merighi A, Corbascio D, Rottigni V, Fistetto G, Esposito A. Fixed combination of hyaluronic acid and chondroitin-sulphate oral formulation in a randomized double blind, placebo controlled study for the treatment of symptoms in patients with non-erosive gastroesophageal reflux. Eur Rev Med Pharmacol Sci. 2013 Dec;17(24):3272-8.
citation: Pellegatta G, Mangiavillano B, Semeraro R, Auriemma F, Carlani E, Fugazza A, Vespa E, Repici A. The Effect of Hyaluronic Acid and Chondroitin Sulphate-Based Medical Device Combined with Acid Suppression in the Treatment of Atypical Symptoms in Gastroesophageal Reflux Disease. J Clin Med. 2022 Mar 29;11(7):1890. doi: 10.3390/jcm11071890.
citation: Alshehri A, Emil S, Laberge JM, Elkady S, Blumenkrantz M, Mayrand S, Morinville V, Nguyen VH. Lower esophageal sphincter augmentation by endoscopic injection of dextranomer hyaluronic acid copolymer in a porcine gastroesophageal reflux disease model. J Pediatr Surg. 2014 Sep;49(9):1353-9. doi: 10.1016/j.jpedsurg.2014.02.088.