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Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

J

Jagiellonian University

Status

Unknown

Conditions

Obesity, Morbid

Treatments

Procedure: bariatric surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04471077
1072.6120.196.2018

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Favorable outcome of bariatric surgery
Description:
Excess weight loss above 50%
Treatment:
Procedure: bariatric surgery
Unfavorable outcome of bariatric surgery
Description:
Excess weight loss below 50%
Treatment:
Procedure: bariatric surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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