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

NCT ID: NCT05085769

Last Updated: 2021-10-20

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

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-01

Study Completion Date

2019-08-01

Brief Summary

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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

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Conditions

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Obesity Bariatric Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

15 patients who had bariatric surgery

Bariatric surgery

Intervention Type PROCEDURE

A procedure for morbidly obese patients whose body mass index (BMI) is higher than 40 kg/m2 or 35 kg/m2 and having comorbidities of obesity.

Control group-1

8 morbidly obese participants who did not have bariatric surgery

No interventions assigned to this group

Control group-2

11 participants who were non-obese

No interventions assigned to this group

Interventions

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Bariatric surgery

A procedure for morbidly obese patients whose body mass index (BMI) is higher than 40 kg/m2 or 35 kg/m2 and having comorbidities of obesity.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

26 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Aslihan Ozdemir

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Ozdemir A, Sarzhanov F, Dogruman-Al F, Gundogdu A, Nalbantoglu U, Yozgat A, Yildiz BD, Buyuktuncer Z. Exploring the complex interplay of Blastocystis, morbid obesity, and bariatric surgery on gut microbial dynamics. Microb Pathog. 2025 Mar;200:107306. doi: 10.1016/j.micpath.2025.107306. Epub 2025 Jan 15.

Reference Type DERIVED
PMID: 39824262 (View on PubMed)

Other Identifiers

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GO14/533

Identifier Type: -

Identifier Source: org_study_id