Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery

Completed

• Conditions: Obesity; Bariatric Surgery
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT05085769
• Lead Sponsor: Hacettepe University

Brief Summary

This study aimed to examine the effects of obesity and bariatric surgery on gut microbiota in a Turkish population, and to contribute to the literature by bringing multi-dimensional parameters including dietary intake, metabolic and inflammatory markers. This case-control study was conducted between June 2015 and August 2019. All participants were followed during the six-month period. Face-to-face interviews and physical examinations were held, and blood and fecal samples were collected at the baseline (M0) and at the end of 3 (M3) and 6 months (M6). Dietary intakes of subjects were assessed using 24-h dietary recall method in each interview and a detailed quantitative food frequency questionnaire that involved 85 food items. Subjects were recruited to the study as three groups: 15 patients who had bariatric surgery as study group, 8 morbidly obese participants who did not have bariatric surgery as control group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as control group-2. All subjects in the study group had sleeve gastrectomy. Subjects in control groups were selected as age and gender matched with the participants in the study group. Individuals were excluded if (a) they were under 19 or above 65 years old, (b) they had an acute or chronic inflammatory disease, (c) they were diagnosed with infectious diseases, cancer or alcohol addiction, (d) they used antibiotics in last 3 months before the screening.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2018-09-01
• Study Completion: 2019-08-01
• Study First Submitted: 2021-09-07
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-19
• Last Update Submitted: 2021-10-19
• Study First Posted: 2021-10-20
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• morbidly obese participants for study and control group-1
• non-obese participants for control group-2

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Exclusion Criteria

• they were under 19 or above 65 years old,
• they had an acute or chronic inflammatory disease,
• they were diagnosed with infectious diseases, cancer or alcohol addiction,
• they used antibiotics in last 3 months before the screening.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Bariatric surgery	15 patients who had bariatric surgery

Primary Outcome Measures

Name	Time	Method
Changes in gut microbial profiles of participants	6 months	Changes in bacterial phyla and sub-phylum levels
Changes in gut bacterial biodiversity of participants	6 months	Changes in gut bacterial alpha and beta biodiversity of participants

Secondary Outcome Measures

Name	Time	Method
Changes in food intakes	6 months	Changes in certain food groups in grams
Changes in dietary energy and nutrient intakes	6 months	Changes in dietary energy in calories, macro-, micronutrient intakes in grams