Changes of Oral and Intestinal Microbiota After Bariatric Surgery

NCT04582006 | Completed

• 1 other identifier: 1072.6120.196.2018-2
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (2)

• Change of microbiota in oral cavity

  6 months

• Change of microbiota in large intestine

  6 months

Study Arms (2)

LSG

Patients undergoing laparoscopic sleeve gastrectomy.

Procedure: Bariatric surgery

LRYGB

Patients undergoing laparoscopic Roux-en-Y gastric bypass.

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

Surgical treatment of morbid obesity.

LRYGB; LSG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators included patients undergoing surgical treatment for morbid obesity.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

Location

Related Publications (1)

• Stefura T, Zapala B, Gosiewski T, Skomarovska O, Pedziwiatr M, Major P. Changes in the Composition of Oral and Intestinal Microbiota After Sleeve Gastrectomy and Roux-En-Y Gastric Bypass and Their Impact on Outcomes of Bariatric Surgery. Obes Surg. 2022 May;32(5):1439-1450. doi: 10.1007/s11695-022-05954-9. Epub 2022 Feb 21.

  PMID: 35188608 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: December 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: December 30, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)