Bariatric SurgeryOROBESITENCT06781229
Periodontal Microbiota of Patients Candidates for Bariatric Surgery With Body Mass Index Greater Than 30
An observational study of Bariatric Surgery and Obesity, Morbid, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Obesity, Morbid
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2025to 3 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients scheduled to undergo bariatric surgery
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephanie BRAYER, Clinical Trial Assistant, master's degree contact
About this study
Official title: Non-interventional Study Exploring the Composition of the Periodontal Microbiota of Patients With Body Mass Index Greater Than 30 That Are Candidates for Bariatric Surgery
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.
Read the detailed description
The study is a non-interventional, single-centre, cross-sectional, comparative study with prospective and consecutive recruitment of participants.
Participants who are scheduled to undergo bariatric surgery as part of their regular medical care will
- during the odontological visit of approximately one hour:
- complete standard odontology medical questionnaire
- complete the dietary hygiene questionnaire: "Etude Nationale Nutrition Santé" questionnaire
- complete 2 quality of life questionnaires: EQ-5D-5L questionnaire and GOHAI self-questionnaire
- undergo clinical examination (visual examination and partial periodontal probing),
- Radiological check-up (panoramic X-ray) and biological check-up (salivary and periodontal samples (non-invasive).
- During bariatric surgery, surgical techniques create surgical waste. From this operative waste, fragments of visceral adipose tissue may be recovered and, if the surgery so requires, subcutaneous adipose tissue (quantity recovered: 5g of visceral adipose tissue and 5g of subcutaneous adipose tissue). The samples taken will be stored in a hospital tissue bank with a view to possible future re-use. Each patient will be informed of this during the inclusion visit.
- Conditions
- Bariatric Surgery, Obesity, Morbid
- Keywords
- microbiological composition, obese, bypass, Body mass index
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : obesity : 30 ≤ BMI < 35 | Obese patients with 30 ≤ BMI < 35 | |
| Group 2 : morbid obesity : 35 ≤ BMI | Morbid obese patients with 35 ≤ BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taxonomic analysis
Taxonomic analysis of the microbiological composition of the periodontal plaque between group 1 (obesity) and 2 (morbid obesity) : relative quantities of periodontal bacteria between group 1 (obesity) and 2 (morbid obesity)
Measured: before bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start3 Feb 2025
- Primary completion3 Feb 2028 (estimated)
- Study completion3 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781229
- Sponsor's protocol ID
- RC31/24/0432
- Acronym
- OROBESITE
- Status last verified
- May 2026
- First submitted
- 13 Jan 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study Exploring the Composition of the Periodontal Microbiota of Patients With Body Mass Index Greater Than 30 That Are Candidates for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06781229
- Acronym / sponsor ID
- OROBESITE / RC31/24/0432
- Conditions
- Bariatric Surgery, Obesity, Morbid
- Keywords
- microbiological composition, obese, bypass, Body mass index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Feb 2028 (estimated)
- Study completion
- 3 Feb 2028 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a non-interventional, single-centre, cross-sectional, comparative study with prospective and consecutive recruitment of participants.
Participants who are scheduled to undergo bariatric surgery as part of their regular medical care will
- during the odontological visit of approximately one hour:
- complete standard odontology medical questionnaire
- complete the dietary hygiene questionnaire: "Etude Nationale Nutrition Santé" questionnaire
- complete 2 quality of life questionnaires: EQ-5D-5L questionnaire and GOHAI self-questionnaire
- undergo clinical examination (visual examination and partial periodontal probing),
- Radiological check-up (panoramic X-ray) and biological check-up (salivary and periodontal samples (non-invasive).
- During bariatric surgery, surgical techniques create surgical waste. From this operative waste, fragments of visceral adipose tissue may be recovered and, if the surgery so requires, subcutaneous adipose tissue (quantity recovered: 5g of visceral adipose tissue and 5g of subcutaneous adipose tissue). The samples taken will be stored in a hospital tissue bank with a view to possible future re-use. Each patient will be informed of this during the inclusion visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : obesity : 30 ≤ BMI < 35 | – | –Obese patients with 30 ≤ BMI < 35 |
| Group 2 : morbid obesity : 35 ≤ BMI | – | –Morbid obese patients with 35 ≤ BMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients scheduled to undergo bariatric surgery
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Taxonomic analysis
Time frame: before bariatric surgery
Taxonomic analysis of the microbiological composition of the periodontal plaque between group 1 (obesity) and 2 (morbid obesity) : relative quantities of periodontal bacteria between group 1 (obesity) and 2 (morbid obesity)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie BRAYER, Clinical Trial Assistant, master's degree contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Obesity, Morbid, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie BRAYER, Clinical Trial Assistant, master's degree (0561322509, Brayer.Stephanie@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taxonomic analysis (time frame: before bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.