Changes of Oral and Intestinal Microbiota After Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582006
• Other study ID #: 1072.6120.196.2018-2
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: January 1, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
Surgical treatment of morbid obesity.

Locations

Country	Name	City	State
Poland	2nd Department of General Surgery, Jagiellonian University Medical College	Cracovia	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of microbiota in oral cavity		6 months
Primary	Change of microbiota in large intestine		6 months