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Spit test may spot reflux risk after gastric sleeve surgery

NCT ID NCT07607067

Knowledge-focused Sponsor: Hospital de Mataró Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether measuring bile acids and pepsin in saliva can help identify people who develop acid reflux or esophageal damage after sleeve gastrectomy (a type of weight-loss surgery). About 60 adults will give saliva samples before surgery and again 1 and 3 years after, along with routine check-ups and questionnaires. The goal is to see if these saliva tests could become a simple way to predict who needs follow-up care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with severe obesity undergoing primary sleeve gastrectomy as part of routine clinical care at participating bariatric centers, without previous conclusive reflux-related esophageal disease on preoperative upper gastrointestinal endoscopy. Participants will be prospectively evaluated before and after surgery with saliva biomarker analysis, reflux symptom assessment, and routine postoperative endoscopic follow-up.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Barrett esophagus gastroesophageal reflux disease obesity disorder peptic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Barrett esophagus Reflux disease, gastro-esophageal Reflux esophagitis (RE) Saliva collection Sleeve gastrectomy

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.