Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease After Sleeve Gastrectomy

Sponsor
Hospital de Mataró
Study ID
NCT07607067
Status
Not Yet Recruiting

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Conditions

  • Barrett Esophagus
  • Reflux Disease, Gastro-Esophageal
  • Reflux Esophagitis (RE)
  • Saliva Collection
  • Sleeve Gastrectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

The goal of this observational study is to learn whether bile acids and pepsin in saliva can help identify adults at higher risk of developing reflux-related esophageal disease after sleeve gastrectomy, including Los Angeles grade B-D erosive esophagitis and Barrett's esophagus. The study will include adults undergoing sleeve gastrectomy as part of their regular clinical care. Participants will be evaluated before and after surgery and will serve as their own comparison group over time. The main questions it aims to answer are: Are saliva bile acids and pepsin linked to Los Angeles grade B-D erosive esophagitis or Barrett's esophagus after sleeve gastrectomy? How do saliva bile acids and pepsin change before and after sleeve gastrectomy? Can saliva bile acids and pepsin become useful biomarkers for detecting reflux-related esophageal disease after sleeve gastrectomy? Are saliva biomarker levels linked to reflux symptoms and endoscopy results after surgery? Researchers will compare saliva biomarker levels before and after surgery and between participants with and without reflux-related esophageal disease. Participants will: Provide saliva samples before surgery and at 12 and 36 months after surgery Provide fasting and post-meal saliva samples Undergo routine postoperative clinical follow-up and upper gastrointestinal endoscopy Complete reflux symptom questionnaires during follow-up The study will also explore whether saliva biomarkers could help select participants for follow-up endoscopy after sleeve gastrectomy.

Key Dates

First listed
May 26, 2026
Start date
Dec 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Sleeve gastrectomy cohort
    Adults undergoing sleeve gastrectomy as part of routine clinical care who are prospectively evaluated before and after surgery with salivary biomarker analysis, symptom assessment, and routine postoperative endoscopic follow-up.

Primary Outcome Measure

Association between salivary bile acid and pepsin concentrations and reflux-related esophageal disease after sleeve gastrectomy [ Time Frame: 12 and 36 months after sleeve gastrectomy ]

Central Contacts

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