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Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

NCT04471077 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-07-16

No results posted yet for this study

Summary

Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We compared samples from patients achieving favorable outcomes in terms of weight-loss with patients, who did not respond optimally to the bariatric operation.

Materials and methods Design 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 ing Group 1 and Group 2. Secondary endpoint was to compare the results of microbiota analysis between LSG and LRYGB.

Conditions

  • Obesity, Morbid

Interventions

PROCEDURE

bariatric surgery

(Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-01-01
Completion
2020-12-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471077 on ClinicalTrials.gov