Changes of Oral and Intestinal Microbiota After Bariatric Surgery

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT04582006
• Lead Sponsor: Jagiellonian University

Brief 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.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2020-01-01
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-09
• Study Completion: 2020-12-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• informed consent to participate in the study
• meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).

Exclusion Criteria

• treatment with antibiotics within 30 days prior to gathering microbiological material
• gastrointestinal infections
• inflammatory bowel disease
• thyroid diseases
• cancer (especially the digestive tract)
• immunodeficiency.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LSG	Bariatric surgery	Patients undergoing laparoscopic sleeve gastrectomy.
LRYGB	Bariatric surgery	Patients undergoing laparoscopic Roux-en-Y gastric bypass.

Primary Outcome Measures

Name	Time	Method
Change of microbiota in oral cavity	6 months
Change of microbiota in large intestine	6 months

Trial Locations

Locations (1)

2nd Department of General Surgery, Jagiellonian University Medical College; 🇵🇱 Cracovia, Małopolska, Poland