Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Esophagogastroduodenoscopy, Simethicone, N-Acetylcysteine, Premedication, Visualization, Esophagogastroduodensocopy (EGD) Procedure, Placebo - Control, Gastritis Associated With Helicobacter Pylori, Tumor Gastric, Lesions in the Esophagus, Stomach, Duodenum or Rectum

In brief

The goal of this randomized, double-blind, placebo-controlled clinical trial is to assess whether the combination of N-acetylcysteine and simethicone improves mucosal visibility during upper gastrointestinal endoscopy in adults aged 18 to 99 years of both sexes, including both healthy individuals and those with non-bleeding gastrointestinal symptoms. The main questions this study aims to answer are: Does pre-endoscopy administration of N-acetylcysteine/simethicone improve mucosal visualization based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS)? Is this combination safe and well tolerated in this patient population? Researchers will compare patients receiving N-acetylcysteine (600 mg) and simethicone (100 mg) orally 20-60 minutes before the procedure with those receiving placebo (water) to determine if there is a significant improvement in TUGS scores. Participants will: Receive a single oral dose of either N-acetylcysteine/simethicone or placebo prior to endoscopy Undergo a routine upper GI endoscopy Have mucosal cleanliness evaluated using the TUGS scoring system Be monitored for any adverse events or intolerance

Key facts

Study ID

NCT07245095

Run by

Hospital General de Mexicali

People needed

132

Starts

2025-09-12

Expected to finish

2026-12-31

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women aged 18 to 70 years old.
• Patients who agree to participate in the clinical trial.
• Patients without active gastrointestinal bleeding.
• Signing of informed consent form.

You may not qualify if…

• Patients with a history of hypersensitivity to N-acetylcysteine
• Patients with a history of hypersensitivity to simethicone
• Patients with a previous endoscopic diagnosis
• Patients with a history of gastric or bariatric surgery
• Patients with a history of motor disorders (e.g., scleroderma, diabetic gastroparesis)
• Patients taking medications that delay gastric emptying (GLP-1 analogues)
• Pregnant or breastfeeding patients
• Patients who do not agree to participate in the clinical trial

Where it is running

• Hospital Almater — Mexicali, Estado de Baja California, Mexico (enrolling)
• Hospital General de Mexicali — Mexicali, Estado de Baja California, Mexico (enrolling)

Full record on ClinicalTrials.gov

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