Changes of Oral and Intestinal Microbiota After Bariatric Surgery

• Sponsor: Jagiellonian University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04582006
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Bariatric surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
LSG Patients undergoing laparoscopic sleeve gastrectomy.	Procedure: Bariatric surgery; Surgical treatment of morbid obesity.
LRYGB Patients undergoing laparoscopic Roux-en-Y gastric bypass.	Procedure: Bariatric surgery; Surgical treatment of morbid obesity.

Outcome Measures

Primary Outcome Measures

1. Change of microbiota in oral cavity [6 months]

2. Change of microbiota in large intestine [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd Department of General Surgery, Jagiellonian University Medical College	Cracovia	Małopolska	Poland	30-688

Sponsors and Collaborators

• Jagiellonian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tomasz Stefura, Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor, Jagiellonian University
• ClinicalTrials.gov Identifier: NCT04582006
• Other Study ID Numbers: 1072.6120.196.2018-2
• First Posted: Oct 9, 2020
• Last Update Posted: Feb 10, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity, Morbid

Study Results

No Results Posted as of Feb 10, 2021