ObesityNCT05085769
Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery
An observational study of Obesity and Bariatric Surgery, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- morbidly obese participants for study and control group-1
- non-obese participants for control group-2
Who cannot join
- 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.
About this study
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.
- Conditions
- Obesity, Bariatric Surgery
- Being tested
- Bariatric surgery
- Keywords
- obesity, bariatric surgery, gut microbiome, diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | 15 patients who had bariatric surgery Receives: Procedure: Bariatric surgery | |
| Control group-1 | 8 morbidly obese participants who did not have bariatric surgery | |
| Control group-2 | 11 participants who were non-obese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbial profiles of participants
Changes in bacterial phyla and sub-phylum levels
Measured: 6 months
Changes in gut bacterial biodiversity of participants
Changes in gut bacterial alpha and beta biodiversity of participants
Measured: 6 months
Secondary outcomes (2)
Changes in dietary energy and nutrient intakes
Changes in dietary energy in calories, macro-, micronutrient intakes in grams
Measured: 6 months
Changes in food intakes
Changes in certain food groups in grams
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Jun 2015
- Primary completion1 Sep 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Ozdemir, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085769
- Sponsor's protocol ID
- GO14/533
- Status last verified
- Oct 2021
- First submitted
- 7 Sep 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39824262
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05085769
- Acronym / sponsor ID
- GO14/533
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- obesity, bariatric surgery, gut microbiome, diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Bariatric surgery15 patients who had bariatric surgery |
| Control group-1 | – | –8 morbidly obese participants who did not have bariatric surgery |
| Control group-2 | – | –11 participants who were non-obese |
Who may qualify
- Ages
- 26 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- morbidly obese participants for study and control group-1
- non-obese participants for control group-2
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryA 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. | Procedure or surgery | Study group |
Primary outcome
Changes in gut microbial profiles of participants
Time frame: 6 months
Changes in bacterial phyla and sub-phylum levels
Changes in gut bacterial biodiversity of participants
Time frame: 6 months
Changes in gut bacterial alpha and beta biodiversity of participants
2 secondary outcomes
Changes in dietary energy and nutrient intakes
Time frame: 6 months
Changes in food intakes
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Derived from this study: PubMed 39824262Ozdemir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbial profiles of participants (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05085769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.