Evaluation of the Clinical Course of NERD and Assessment of the Esophageal Mucosa Resistance

NCT07174882 | Active Not Recruiting DMC

• 1 other identifier: 29091973
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

GERD is characterized by a high prevalence (about 13.3%) and is associated with a deterioration in the quality of life, as well as an increased risk of esophageal adenocarcinoma and a rise in the number of refractory cases. NERD is one of the forms of GERD, accounting for about 70% of all cases, and is characterized by symptoms that reduce the quality of life. Although proton pump inhibitors (PPIs) are the basic therapy for NERD, up to 40% of patients do not achieve an optimal clinical outcome. GERD symptoms seriously affect the quality of life and performance, which makes the study of complex therapy relevant. One of the mechanisms of GERD is a violation of the barrier function of the esophageal mucosa, associated with an increase in epithelial permeability due to the dysfunction of intercellular junction proteins, such as claudins and occludin. The study of methods to increase tissue resistance and cytoprotection, together with acid-suppressive therapy, is a promising direction, especially for refractory forms of NERD. It is relevant to study the complex treatment of NERD in order to change the clinical course of the disease and improve the tissue resistance of the esophageal mucosa. These hypotheses and theses emphasize the need for a comprehensive approach to the treatment of NERD and a research focus on improving the barrier functions of the esophagus

Conditions

Non-Erosive Gastro-Esophageal Reflux Disease; Gastroesophageal Reflux Disease (GERD)

Keywords

GERD; NERD; rebamipide; epithelial resistance; cytoprotection

Outcome Measures

Primary Outcomes (3)

• Assess the intensity of symptoms

  Assess the intensity of symptoms using a SYMPTOM INTENSITY QUESTIONNAIRE ON THE LIKERT SCALE (including intensity of heartburn, regurgitation, chest pain, belching, cough, and sensation of mucus in the throat). 5-point scale: 1. Symptom absent 2. Mild symptom, occasionally present 3. Moderate symptom 4. Severe symptom 5. Persistent symptom

  Before treatment and 4 weeks after the start of therapy

• Examine the inflammatory changes in the esophageal mucosa.

  Examine the inflammatory changes in the esophageal mucosa (such as dilated intercellular spaces, intraepithelial eosinophils, intraepithelial neutrophils, intraepithelial mononuclear cells, basal cell hyperplasia, elongation of papillae in the lamina propria, and spongiosis) through morphological examination.

  Before treatment and again 4 weeks after the start of therapy.

• Study the expression of tight junction proteins in esophageal mucosa.

  Study the expression of tight junction proteins in esophageal mucosa samples by immunohistochemistry.

  Before treatment and 4 weeks after the start of therapy.

Secondary Outcomes (8)

• Assess the сhange in Acid Exposure Time (%)

  Before treatment and 4 weeks after the start of therapy

• Change in Total Number of Gastroesophageal Reflux Episodes

  Before treatment and 4 weeks after the start of therapy

• Change in Number of Proximal Reflux Episodes

  Before treatment and 4 weeks after the start of therapy

• Change in Composition of Reflux Episodes (Liquid, Mixed, Gas)

  Before treatment and 4 weeks after the start of therapy

• Change in Mean Nocturnal Baseline Impedance (MNBI) (Ohms)

  Before treatment and 4 weeks after the start of therapy

Study Arms (2)

Main group (intervention group): 30 patients

Participants in the main group will receive combination therapy with a proton pump inhibitor and rebamipide for 4 weeks.

Control group: 30 patients

Participants in the control group will receive monotherapy with a proton pump inhibitor for 4 weeks.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatient both gender from 18 to 75 years old

You may qualify if:

• The availability of written informed consent from the patient to participate in the study.
• Patients aged over 18 years.
• Gender: both men and women.
• The patient must be able to independently fill out questionnaires and assess their condition using scales.
• A confirmed diagnosis of non-erosive reflux disease.

You may not qualify if:

• The voluntary withdrawal of consent to participate in the study by the patient.
• Pregnancy.
• The patient experienced a serious adverse event, the relationship of which to the study drug is classified as definite, probable, or possible.
• The patient is receiving/requires additional treatment that may affect the efficacy parameters being studied.
• Protocol violations that, in the opinion of the investigator, are significant for the results of the clinical trial.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

V.Kh.Vasilenko Clinic of Propedeutics of Internal Diseases, Gastroenterology and Hepatology, I.M.Sechenov First Moscow State Medical University (Sechenov University). Gastroenterology department, outpatient clinic.

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: September 16, 2025
• Study Start: February 20, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 13, 2025
• Last Updated: September 16, 2025

Record last verified: 2024-12

Locations

RU (1)