Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

• Conditions: Obesity, Morbid
• Interventions: Procedure: bariatric surgery

• Registration Number: NCT04471077
• Lead Sponsor: Jagiellonian University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2020-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-14
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unfavorable outcome of bariatric surgery	bariatric surgery	Excess weight loss below 50%
Favorable outcome of bariatric surgery	bariatric surgery	Excess weight loss above 50%

Primary Outcome Measures

Name	Time	Method
Change of microbiota in large intestine	6 months
Change of microbiota in oral cavity	6 months

Trial Locations

Locations (1)

2nd Department of General Surgery, Jagiellonian University Medical College; 🇵🇱 Cracovia, Małopolska, Poland