Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool (METABIOM)

April 11, 2023 updated by: Michael Jelden, University Hospital, Saarland

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg/Saar, Germany, D-66421
        • Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with obesity

Description

Inclusion Criteria:

  • abdominal surgery containing opening of jejunum
  • singing of consent

Exclusion Criteria:

  • inflammative condition (appendicitis, pancreatitis, Crohn, Colitis ulcerous, cholecystitis and similar)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Subjects to undergo surgery including opening of the jejunum with non-inflammative condition.
Diagnostic test: Microbial Swab
Swabs will be taken from peritoneum and jejunum (intraoperatively), rectum, and stool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of microbiome
Time Frame: intra-operative
Previously uncharacterized sites: jejunum, peritoneum
intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Collaborators

Universität des Saarlandes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METABIOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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