Morbid ObesityNCT04582006
Changes of Oral and Intestinal Microbiota After Bariatric Surgery
An observational study of Morbid Obesity, run by Jagiellonian University at 1 site in Poland.
Trial summary
Purpose The aim of this study was to analyze the changes of microbiota among patients undergoing LSG or LRYGB on two levels of gastrointestinal tract (using oral swab and stool sample). We compared samples from patients before and after bariatric operation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Adult, Older adult
Study population: The investigators included patients undergoing surgical treatment for morbid obesity.
Who may be able to join
- informed consent to participate in the study
- meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).
Who cannot join
- treatment with antibiotics within 30 days prior to gathering microbiological material
- gastrointestinal infections
- inflammatory bowel disease
- thyroid diseases
- cancer (especially the digestive tract)
- immunodeficiency.
Trial locations and contacts
1 site in 1 country.
Poland1 site
2nd Department of General Surgery, Jagiellonian University Medical College
Krakow, Małopolska, 30-688
About this study
Official title: Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass
Purpose
The aim of this study was to analyze the changes of microbiota among patients undergoing LSG or LRYGB on two levels of gastrointestinal tract (using oral swab and stool sample). We compared samples from patients before and after bariatric operation.
Read more
Materials and methods This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2.
Analysis and endpoints
Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients before and after bariatric surgery. Secondary endpoint was to compare the difference in microbiota changes between patients undergoing LSG and LRYGB
- Conditions
- Morbid Obesity
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Surgical treatment of morbid obesity.
| Study group | Role | What they receive |
|---|---|---|
| LSG | Patients undergoing laparoscopic sleeve gastrectomy. Receives: Procedure: Bariatric surgery | |
| LRYGB | Patients undergoing laparoscopic Roux-en-Y gastric bypass. Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of microbiota in oral cavity
Measured: 6 months
Change of microbiota in large intestine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Dec 2018
- Primary completion1 Jan 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Stefura, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582006
- Sponsor's protocol ID
- 1072.6120.196.2018-2
- Status last verified
- Feb 2021
- First submitted
- 5 Oct 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planing to share data.
Publications
Stefura T, Zapala B, Gosiewski T, Skomarovska O, Pedziwiatr M, Major P. Changes in the Composition of Oral and Intestinal Microbiota After Sleeve Gastrectomy and Roux-En-Y Gastric Bypass and Their Impact on Outcomes of Bariatric Surgery. Obes Surg. 2022 May;32(5):1439-1450. doi: 10.1007/s11695-022-05954-9. Epub 2022 Feb 21.
PubMed 35188608
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT04582006
- Acronym / sponsor ID
- 1072.6120.196.2018-2
- Conditions
- Morbid Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 9 Oct 2020 (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.
Purpose
The aim of this study was to analyze the changes of microbiota among patients undergoing LSG or LRYGB on two levels of gastrointestinal tract (using oral swab and stool sample). We compared samples from patients before and after bariatric operation.
Materials and methods This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2.
Analysis and endpoints
Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients before and after bariatric surgery. Secondary endpoint was to compare the difference in microbiota changes between patients undergoing LSG and LRYGB
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG | – | Procedure: Bariatric surgeryPatients undergoing laparoscopic sleeve gastrectomy. |
| LRYGB | – | Procedure: Bariatric surgeryPatients undergoing laparoscopic Roux-en-Y gastric bypass. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators included patients undergoing surgical treatment for morbid obesity.
Key inclusion criteria (2 listed)
- informed consent to participate in the study
- meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).
Key exclusion criteria (6 listed)
- treatment with antibiotics within 30 days prior to gathering microbiological material
- gastrointestinal infections
- inflammatory bowel disease
- thyroid diseases
- cancer (especially the digestive tract)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgerySurgical treatment of morbid obesity. | Procedure or surgery | LRYGB, LSG |
Primary outcome
Change of microbiota in oral cavity
Time frame: 6 months
Change of microbiota in large intestine
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 35188608Stefura T, Zapala B, Gosiewski T, Skomarovska O, Pedziwiatr M, Major P. Changes in the Composition of Oral and Intestinal Microbiota After Sleeve Gastrectomy and Roux-En-Y Gastric Bypass and Their Impact on Outcomes of Bariatric Surgery. Obes Surg. 2022 May;32(5):1439-1450. doi: 10.1007/s11695-022-05954-9. Epub 2022 Feb 21.
- Individual participant dataSharing planned: No. We are not planing to share data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Morbid Obesity, run by Jagiellonian University at 1 site in Poland.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 10 Feb 2021. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of microbiota in oral cavity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582006, which also lists 1 linked publication.
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 10 Feb 2021.