RecruitingNot Applicable

Periodontal Microbiota of Patients Candidates for Bariatric Surgery With Body Mass Index Greater Than 30

France170 participantsStarted 2025-02-03

Plain-language summary

The goal of this observational study is to compare the microbiological composition of the periodontal plaque of obese people undergoing bariatric surgery according to their Body Mass Index. The main question it aims to answer is: Does obese patients have different microbiote according to their obesity? Obesity being classified in two groups : * group "obesity" for a BMI between 30 and 35 * versus "morbid obesity" group with a BMIabove 35. Participants who are scheduled to undergo bariatric surgery as part of their regular medical care will answer questions about their quality of life, hygiene habits, and saliva and periodontal samples will be taken.

Who can participate

Age range

18 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: * BMI greater than or equal to 30 * Be on the list of patients scheduled for bariatric surgery, * Be able to receive information about the study and understand the information form in order to take part in the study. This implies mastering the French language, Exclusion Criteria: * Alcohol consumption \>30g/d (men) or 20g/d (women), * Having taken antibiotics, prebiotics or probiotics in the month prior to inclusion (this has an influence on the composition of the patient's microbiota), * During pregnancy or breastfeeding, * For whom oral surgery is planned (surgery for benign or malignant tumours of the maxillary and mandibular bone bases), or with a history of oral surgery in the month prior to inclusion, * At risk of infection (existence of one or more of the following known chronic infectious diseases: HIV, HBV, HCV and mononucleosis) and/or chronic renal insufficiency (creatinine clearance \< 60ml/min), * Patients with a general pathology that contraindicates the performance of diagnostic procedures such as periodontal probing (patients at high risk of infective endocarditis according to the ANSM). * Totally edentulous patients

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

Taxonomic analysis

Timeframe: before bariatric surgery

Trial details

NCT IDNCT06781229

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-03

Contact for this trial

Stephanie BRAYER, Clinical Trial Assistant, master's degree

0561322509 Brayer.Stephanie@iuct-oncopole.fr

View on ClinicalTrials.gov More Bariatric Surgery trials