Changes of Oral and Intestinal Microbiota After Bariatric Surgery
NCT ID: NCT04582006
Last Updated: 2021-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-12-01
2020-12-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LSG
Patients undergoing laparoscopic sleeve gastrectomy.
Bariatric surgery
Surgical treatment of morbid obesity.
LRYGB
Patients undergoing laparoscopic Roux-en-Y gastric bypass.
Bariatric surgery
Surgical treatment of morbid obesity.
Interventions
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Bariatric surgery
Surgical treatment of morbid obesity.
Eligibility Criteria
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Inclusion Criteria
* meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).
Exclusion Criteria
* gastrointestinal infections
* inflammatory bowel disease
* thyroid diseases
* cancer (especially the digestive tract)
* immunodeficiency.
18 Years
65 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Tomasz Stefura
Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor
Locations
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2nd Department of General Surgery, Jagiellonian University Medical College
Krakow, Małopolska, Poland
Countries
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References
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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.
Other Identifiers
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1072.6120.196.2018-2
Identifier Type: -
Identifier Source: org_study_id
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