NCT05085769

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

Completed Last updated 20 October 2021

What this trial tests

trial testing Bariatric surgery in Obesity in 34 participants. Completed in 1 August 2019.

Timeline

1 June 2015

Primary endpoint
1 September 2018

1 August 2019

Quick facts

Lead sponsor	Hacettepe University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	34
Start date	1 June 2015
Primary completion	1 September 2018
Estimated completion	1 August 2019

Drugs / interventions tested

• Bariatric surgery

Conditions studied

• Obesity — all drugs for Obesity →
• Bariatric Surgery — all drugs for Bariatric Surgery →

Sponsor

Hacettepe University

Who can join

Adults 26 to 60, any sex, with Obesity or Bariatric Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploring the complex interplay of Blastocystis, morbid obesity, and bariatric surgery on gut microbial dynamics.
   Özdemir A, Sarzhanov F, Doğruman-Al F, Gündoğdu A, et al · · 2025 · PMID 39824262 · DOI 10.1016/j.micpath.2025.107306