Association Between Outcomes of Bariatric Surgery and Preoperative Gastrointestinal Microbiota

NCT ID: NCT04471077

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-12-30

Brief Summary

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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

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Conditions

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Obesity, Morbid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Favorable outcome of bariatric surgery

Excess weight loss above 50%

bariatric surgery

Intervention Type PROCEDURE

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

Unfavorable outcome of bariatric surgery

Excess weight loss below 50%

bariatric surgery

Intervention Type PROCEDURE

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

Interventions

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bariatric surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Tomasz Stefura

Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, Poland

Site Status

Countries

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Poland

Other Identifiers

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1072.6120.196.2018

Identifier Type: -

Identifier Source: org_study_id

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