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Completed

NCT Number: NCT04582006

Changes of Oral and Intestinal Microbiota After Bariatric Surgery

Purpose

The aim of this study was to analyze the changes of microbiota among patients undergoing LSG or LRYGB on two levels of gastrointestinal tract (using oral swab and stool sample). We compared samples from patients before and after bariatric operation.

Materials and methods 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 before and after bariatric surgery. Secondary endpoint was to compare the difference in microbiota changes between patients undergoing LSG and LRYGB

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent to participate in the study
  • meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).

Exclusion criteria

  • treatment with antibiotics within 30 days prior to gathering microbiological material
  • gastrointestinal infections
  • inflammatory bowel disease
  • thyroid diseases
  • cancer (especially the digestive tract)
  • immunodeficiency.

Treatment and study plan

bariatric surgery

Procedure

Surgical treatment of morbid obesity.

Primary outcomes

  1. Change of microbiota in oral cavity

    Time frame: 6 months

  2. Change of microbiota in large intestine

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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