Changes of Oral and Intestinal Microbiota After Bariatric Surgery

Jagiellonian University

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: Bariatric surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04582006

1072.6120.196.2018-2

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

LSG

Description:

Patients undergoing laparoscopic sleeve gastrectomy.

Treatment:

Procedure: Bariatric surgery

LRYGB

Description:

Patients undergoing laparoscopic Roux-en-Y gastric bypass.

Treatment:

Procedure: Bariatric surgery