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

NCT07245095 | Recruiting Phase 2

• 1 other identifier: NACSIMET-ETDA-MEX2025
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Keywords

Esophagogastroduodenoscopy; Mucous Membrane; Premedication; Simethicone; Acetylcysteine; Gastrointestinal Tract

Outcome Measures

Primary Outcomes (1)

• Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)

  The Toronto Upper Gastrointestinal Cleaning Score (TUGCS) is a validated scale that assesses mucosal cleanliness/visualization across four upper GI areas (fundus, body, antrum, and duodenum). Each area is scored from 0 to 3 (0 = poorest visualization; 3 = entire mucosa visible without suctioning/washing). The total score is the sum of all four areas (range 0-12). Higher scores indicate better mucosal cleanliness/visibility. Scoring is performed by blinded assessors during the procedure using standardized criteria.

  During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication).

Secondary Outcomes (5)

• Detection of Mucosal Lesions

  During endoscopy procedure

• Complete Esophageal Visualization

  During endoscopy.

• Histological gastritis according to the Updated Sydney System (0-3 per item) and OLGA/OLGIM staging (0-IV)

  Biopsies obtained during the index endoscopy (Day 0); histopathological report within 14 days

• Presence and density of Helicobacter pylori by histology (Updated Sydney System 0-3)

  Biopsies obtained during the index endoscopy (Day 0); report within 14 days

• Number of histologically confirmed neoplasic lesions per patient

  During the index endoscopy (Day 0) and histological confirmation up to 14 days

Study Arms (2)

Patients receiving n-acetylcysteine/simethicone

ACTIVE COMPARATOR

Drug: Premedication with n-acetylcysteine; Drug: Premedication with simethicone

Patients receiving placebo

PLACEBO COMPARATOR

Drug: Placebo (drinking water)

Interventions

Premedication with n-acetylcysteine DRUG

Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting.

Patients receiving n-acetylcysteine/simethicone

Placebo (drinking water) DRUG

The control group will receive an equivalent placebo infusion (composed of drinking water)

Patients receiving placebo

Premedication with simethicone DRUG

Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the "Randomized for Clinical Trial" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting

Patients receiving n-acetylcysteine/simethicone

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hospital General de Mexicali: lead

Study Sites (2)

Hospital Almater

Mexicali, Estado de Baja California, 21000, Mexico

RECRUITING

Hospital General de Mexicali

Mexicali, Estado de Baja California, 21100, Mexico

RECRUITING

Related Publications (8)

• Devereaux BM, Taylor ACF, Athan E, Wallis DJ, Brown RR, Greig SM, Bailey FK, Vickery K, Wardle E, Jones DM. Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological Society of Australia. J Gastroenterol Hepatol. 2019 Dec;34(12):2086-2089. doi: 10.1111/jgh.14757. Epub 2019 Jul 28.

  PMID: 31242327 BACKGROUND

• Manfredi G, Berte R, Iiritano E, Alicante S, Londoni C, Brambilla G, Romeo S, Menozzi F, Griffanti P, Brandi G, Moreschi O, Pezzilli R, Zullo A, Buscarini E. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open. 2021 Feb;9(2):E190-E194. doi: 10.1055/a-1315-0114. Epub 2021 Jan 25.

  PMID: 33532557 BACKGROUND

• Monrroy H, Vargas JI, Glasinovic E, Candia R, Azua E, Galvez C, Rojas C, Cabrera N, Vidaurre J, Alvarez N, Gonzalez J, Espino A, Gonzalez R, Parra-Blanco A. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointest Endosc. 2018 Apr;87(4):986-993. doi: 10.1016/j.gie.2017.10.005. Epub 2017 Oct 14.

  PMID: 29037773 BACKGROUND

• Beaufort IN, Verbeek RE, Bosman JH, Al-Toma A, Bogte A, Alvarez Herrero L, Weusten BLAM. Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial. Endosc Int Open. 2023 Oct 17;11(10):E992-E1000. doi: 10.1055/a-2157-5034. eCollection 2023 Oct.

  PMID: 37854124 BACKGROUND

• Mahawongkajit P, Kanlerd A. A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy. Surg Endosc. 2021 Jan;35(1):303-308. doi: 10.1007/s00464-020-07397-8. Epub 2020 Feb 3.

  PMID: 32016519 RESULT

• Chang WK, Yeh MK, Hsu HC, Chen HW, Hu MK. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. J Gastroenterol Hepatol. 2014 Apr;29(4):769-74. doi: 10.1111/jgh.12487.

  PMID: 24325147 RESULT

• Sajid MS, Rehman S, Chedgy F, Singh KK. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone +/- N-acetylcysteine. Transl Gastroenterol Hepatol. 2018 May 19;3:29. doi: 10.21037/tgh.2018.05.02. eCollection 2018.

  PMID: 29971260 RESULT

• Li Y, Du F, Fu D. The effect of using simethicone with or without N-acetylcysteine before gastroscopy: A meta-analysis and systemic review. Saudi J Gastroenterol. 2019 Jul-Aug;25(4):218-228. doi: 10.4103/sjg.SJG_538_18.

  PMID: 31044749 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Premedication; Acetylcysteine; Drinking Water; Simethicone

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Luis Andre Sanchez Perez, Resident

CONTACT

+ 52 6863468689; sanchez.luis3@uabc.edu.mx

Jesus Alberto Camacho Escobedo, Gastroenterologist

CONTACT

+ 52 6862146050; jesus13camacho@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: November 24, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available beginning 6 months after publication of the main results and for up to 3 years thereafter.
• Access Criteria: Researchers whose proposed use of the data has been approved by the study's principal investigator.

Locations

ME (2)