Gastroesophageal RefluxNCT05561179
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
A study testing Hyaluronic acid injection in people with Gastroesophageal Reflux, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Hyaluronic acid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEcuador
- Study dates
- 30 Sep 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Guayaquil, Guayas, 090505
Carlos Robles-Medranda, MD FASGE, +59342109180, carlosoakm@yahoo.es
Hannah Pitanga-Lukashok, MD
About this study
Official title: Hyaluronic Acid as a Novel Therapeutic Approach for Patients With GERD: a Single-center Study
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Hyaluronic acid injection, Sodium chloride injection (control group)
- Keywords
- Gastroesophageal Reflux, hyaluronic acid, Esophageal Sphincter
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid injectionProcedure or surgery
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.
Sodium chloride injection (control group)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| GERD + HA injections | Experimental | 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. Receives: Procedure: Hyaluronic acid injection |
| GERD without HA injections | Placebo comparator | 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. Receives: Procedure: Sodium chloride injection (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acid exposure to the distal esophagus after intervention
The response to the therapy will be determined by the acid exposure to the distal esophagus, measured through pH monitoring and evaluated by 24-h acid exposure time (AET). AET is defined as the total time for which the pH in the distal esophagus is below 4 divided by the total duration of Multichannel Intraluminal Impedance (MII)-pH monitoring. It is expressed in percentages. AET of more than 4% is considered an abnormal distal esophageal acid exposure.
The patients will be assessed at the beginning, one and six months after the procedure.
Measured: Up to 6 months
Assessment of esophageal transit and gastric emptying
The assessment of gastrointestinal transit through barium x-ray (upper gastrointestinal series) to identify any post-procedural functional motility changes.
The patients will be assessed one month after the procedure.
Measured: Up to 1 month
Change in health-related quality of life
Effect in the Gastroesophageal Reflux Disease Health-related quality of life through the Northwestern Esophageal Quality of Life (NEQOL) scale. NEQOL, a 14-item, single scale measure of Health-related quality of life (HRQOL), allows for rapid assessment in a clinical setting.
The patients will be assessed at the beginning, and six months after the procedure.
Measured: up to 6 months
Secondary outcomes (2)
Evaluation of lower esophageal sphincter (LES) distensibility and pressure by EndoFLIP
Based on pressure and distensibility evaluation of LES by EndoFLIP.
The measure will be made at the beginning, and one month after the procedure.
Measured: Up to 1 month
Safety of HA injections in GERD
Proportion of patients experiencing local adverse events related to the procedure.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start30 Sep 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A non-blinded, single center, randomized prospective trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas
- Investigators
- Carlos Robles-Medranda, MD FASGE, Principal investigator, Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561179
- Sponsor's protocol ID
- IECED-09282022
- Status last verified
- Jan 2023
- First submitted
- 27 Sep 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34807007Martin 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.
PubMed 24345840Palmieri 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.
PubMed 24379055Pellegatta 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.
PubMed 35407497Alshehri 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.
PubMed 25148736
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid as a Novel Therapeutic Approach for Patients With GERD: a Single-center Study
- ClinicalTrials.gov ID
- NCT05561179
- Acronym / sponsor ID
- IECED-09282022
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, hyaluronic acid, Esophageal Sphincter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A non-blinded, single center, randomized prospective trial
| Arm | Type | Receives |
|---|---|---|
| GERD + HA injections | Experimental | Procedure: Hyaluronic acid injectionThis 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. |
| GERD without HA injections | Placebo comparator | Procedure: Sodium chloride injection (control group)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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid injectionPatients 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 or surgery | GERD + HA injections |
| 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. | Procedure or surgery | GERD without HA injections |
Primary outcome
Acid exposure to the distal esophagus after intervention
Time frame: Up to 6 months
The response to the therapy will be determined by the acid exposure to the distal esophagus, measured through pH monitoring and evaluated by 24-h acid exposure time (AET). AET is defined as the total time for which the pH in the distal esophagus is below 4 divided by the total duration of Multichannel Intraluminal Impedance (MII)-pH monitoring. It is expressed in percentages. AET of more than 4% is considered an abnormal distal esophageal acid exposure. The patients will be assessed at the beginning, one and six months after the procedure.
Assessment of esophageal transit and gastric emptying
Time frame: Up to 1 month
The assessment of gastrointestinal transit through barium x-ray (upper gastrointestinal series) to identify any post-procedural functional motility changes. The patients will be assessed one month after the procedure.
Change in health-related quality of life
Time frame: up to 6 months
Effect in the Gastroesophageal Reflux Disease Health-related quality of life through the Northwestern Esophageal Quality of Life (NEQOL) scale. NEQOL, a 14-item, single scale measure of Health-related quality of life (HRQOL), allows for rapid assessment in a clinical setting. The patients will be assessed at the beginning, and six months after the procedure.
2 secondary outcomes
Evaluation of lower esophageal sphincter (LES) distensibility and pressure by EndoFLIP
Time frame: Up to 1 month
Safety of HA injections in GERD
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 34807007Katz 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.
- Background: PubMed 24345840Martin 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.
- Background: PubMed 24379055Palmieri 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.
- Background: PubMed 35407497Pellegatta 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.
- Background: PubMed 25148736Alshehri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Robles-Medranda, MD FASGE principal investigator
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid injection in people with Gastroesophageal Reflux, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Robles-Medranda, MD FASGE (+59342109180, carlosoakm@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acid exposure to the distal esophagus after intervention (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561179, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.