ObesityMETABIOMNCT04067440
Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool
An observational study of Obesity and Diabetes Mellitus, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
Characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Fatty Liver, Nonalcoholic
- What is being tested?
- Microbial Swab
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 30 Jul 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obesity
Who may be able to join
- abdominal surgery containing opening of jejunum
- singing of consent
Who cannot join
- inflammative condition (appendicitis, pancreatitis, Crohn, Colitis ulcerous, cholecystitis and similar)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,
Homburg/Saar, D-66421
About this study
Official title: Characterization and Comparison of the Human Microbiome in Peritoneum, Jejunum, Rectum and Stool
Characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines.
Read the detailed description
Subjects to undergo surgery with opening of the jejunum will be sampled with sterile swabs from peritoneum and the inside of the jejunum. A swab will also be taken from the rectum.
The peritoneum is regarded as a sterile place until today. We try to either verify this, we also could find a scientific base for theories like leaky gut or other forms of bacterial migration through the intestinal wall.
Many of these patients undergo bariatric surgery. Many of them do have a dramatic change in glucose metabolism immediate after surgery. Therefore stool swabs will be taken before and 5 days after surgery.
- Conditions
- Obesity, Diabetes Mellitus, Fatty Liver, Nonalcoholic, Leaky Gut Syndrome, Chronic Pancreatitis
- Being tested
- Microbial Swab
- Keywords
- Microbiome, Obesity, Chronic Liver Disease
- Medical subject headings
- Obesity, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbial SwabDiagnostic test
Swabs will be taken from peritoneum and jejunum (intraoperatively), rectum, and stool
| Study group | Role | What they receive |
|---|---|---|
| Patients | Subjects to undergo surgery including opening of the jejunum with non-inflammative condition. Receives: Diagnostic Test: Microbial Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of microbiome
Previously uncharacterized sites: jejunum, peritoneum
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Jul 2023
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Jelden, University Hospital, Saarland
- Investigators
- Michael Jelden, Dr., Principal investigator, Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067440
- Sponsor's protocol ID
- METABIOM
- Acronym
- METABIOM
- Status last verified
- May 2025
- First submitted
- 21 Aug 2019
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Comparison of the Human Microbiome in Peritoneum, Jejunum, Rectum and Stool
- ClinicalTrials.gov ID
- NCT04067440
- Acronym / sponsor ID
- METABIOM / METABIOM
- Conditions
- Obesity, Diabetes Mellitus, Fatty Liver, Nonalcoholic, Leaky Gut Syndrome, Chronic Pancreatitis
- Keywords
- Microbiome, Obesity, Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 26 Aug 2019 (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.
Characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines.
Detailed description
Subjects to undergo surgery with opening of the jejunum will be sampled with sterile swabs from peritoneum and the inside of the jejunum. A swab will also be taken from the rectum.
The peritoneum is regarded as a sterile place until today. We try to either verify this, we also could find a scientific base for theories like leaky gut or other forms of bacterial migration through the intestinal wall.
Many of these patients undergo bariatric surgery. Many of them do have a dramatic change in glucose metabolism immediate after surgery. Therefore stool swabs will be taken before and 5 days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Microbial SwabSubjects to undergo surgery including opening of the jejunum with non-inflammative condition. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity
Key inclusion criteria (2 listed)
- abdominal surgery containing opening of jejunum
- singing of consent
Key exclusion criteria (1 listed)
- inflammative condition (appendicitis, pancreatitis, Crohn, Colitis ulcerous, cholecystitis and similar)
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 |
|---|---|---|
| Microbial SwabSwabs will be taken from peritoneum and jejunum (intraoperatively), rectum, and stool | Diagnostic test | Patients |
Primary outcome
Characterization of microbiome
Time frame: intra-operative
Previously uncharacterized sites: jejunum, peritoneum
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 29 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Michael Jelden, Dr. principal investigator
Saarland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes Mellitus, run by Universität des Saarlandes at 1 site in Germany.
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 1 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Characterization of microbiome (time frame: intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.