Clinical Trials Directory

Trials / Unknown

UnknownNCT04471077

Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Jagiellonian University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers

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

Interventions

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

Timeline

Start date
2018-12-01
Primary completion
2020-01-01
Completion
2020-12-30
First posted
2020-07-14
Last updated
2020-07-16

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT04471077. Inclusion in this directory is not an endorsement.