Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Obesity, Morbid Clinical Trial

Official title:

Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04471077
• Other study ID #: 1072.6120.196.2018
• Status: Active, not recruiting
• Start date: December 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 30, 2020
• Est. primary completion date: January 1, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• bariatric surgery
(Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)

Locations

Country	Name	City	State
Poland	2nd Department of General Surgery, Jagiellonian University Medical College	Cracovia	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of microbiota in oral cavity		6 months
Primary	Change of microbiota in large intestine		6 months