Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease After Sl… (NCT07607067) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease After Sleeve Gastrectomy
60 participantsStarted 2026-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older undergoing sleeve gastrectomy at a participating center.
* Indication for obesity treatment with sleeve gastrectomy according to the 2022 ASMBS-IFSO consensus criteria, with a maximum body mass index (BMI) of 50 kg/m².
* Approved for sleeve gastrectomy by the obesity multidisciplinary committee.
* Ability and willingness to provide informed consent for biological sample collection and analysis.
* Ability to understand and comply with scheduled follow-up visits.
Exclusion Criteria:
* According to Lyon 2.0 criteria, participants with previous evidence of conclusive reflux disease, including Los Angeles grade B, C, or D esophagitis, peptic stricture, or Barrett's esophagus diagnosed before surgery.
* Bariatric procedures other than sleeve gastrectomy, including Roux-en-Y gastric bypass or revisional bariatric surgery.
* History of other preexisting esophageal diseases.
* Previous esophageal surgery.
* Active cholestatic hepatobiliary disease or treatment with bile acid sequestrants, ursodeoxycholic acid, or medications that significantly alter bile acid metabolism at the time of saliva sampling or within one month before sample collection.
* Acute infection or systemic antibiotic treatment within four weeks before saliva sample collection.
* Pregnancy or breastfeeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between salivary bile acid and pepsin concentrations and reflux-related esophageal disease after sleeve gastrectomy
Timeframe: 12 and 36 months after sleeve gastrectomy