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NCT04067440 Clinical Trial

Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool

Obesity Clinical Trial

— METABIOM  

Official title:
Characterization and Comparison of the Human Microbiome in Peritoneum, Jejunum, Rectum and Stool

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04067440
Other study ID # METABIOM
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date December 30, 2023

Study information
Verified date April 2023
Source Universität des Saarlandes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - abdominal surgery containing opening of jejunum - singing of consent Exclusion Criteria: - inflammative condition (appendicitis, pancreatitis, Crohn, Colitis ulcerous, cholecystitis and similar)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Microbial Swab
Swabs will be taken from peritoneum and jejunum (intraoperatively), rectum, and stool

Locations
Country Name City State
Germany Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, Homburg/Saar

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Saarland Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Characterization of microbiome Previously uncharacterized sites: jejunum, peritoneum intra-operative
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