Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

NCT04471077 | Unknown

• 1 other identifier: 1072.6120.196.2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• Change of microbiota in oral cavity

  6 months

• Change of microbiota in large intestine

  6 months

Study Arms (2)

Favorable outcome of bariatric surgery

Excess weight loss above 50%

Procedure: bariatric surgery

Unfavorable outcome of bariatric surgery

Excess weight loss below 50%

Procedure: bariatric surgery

Interventions

bariatric surgery PROCEDURE

(Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)

Favorable outcome of bariatric surgery; Unfavorable outcome of bariatric surgery

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:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

Location

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: July 10, 2020
• First Posted: July 14, 2020
• Study Start: December 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: December 30, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)