Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Purpose The aim of this study was to analyze the microbiota of patients undergoing LSG or LRYGB on three levels of gastrointestinal tract, using oral swab and stool sample. We compared samples from patients achieving favorable outcomes in terms of weight-loss with patients, who did not respond optimally to the bariatric operation.

Materials and methods Design 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 ing Group 1 and Group 2. Secondary endpoint was to compare the results of microbiota analysis between LSG and LRYGB.

Study Overview

• Status: Unknown
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: bariatric surgery

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Poland
  • Małopolska
    • Cracovia, Małopolska, Poland, 30-688
      • 2nd Department of General Surgery, Jagiellonian University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The investigators included patients undergoing surgical treatment for morbid obesity.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• type 1 or type 2 diabetes, treatment with antibiotics within 30 days prior to gathering microbiological material, treatment with probiotics within 30 days prior to gathering microbiological material, gastrointestinal infections, inflammatory bowel disease, thyroid diseases, cancer (especially the digestive tract), immunodeficiency.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Favorable outcome of bariatric surgery; Excess weight loss above 50%	Procedure: bariatric surgery; (Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)
Unfavorable outcome of bariatric surgery; Excess weight loss below 50%	Procedure: bariatric surgery; (Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of microbiota in oral cavity	6 months
Change of microbiota in large intestine	6 months

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 1072.6120.196.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planing to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No