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
• Status: Active, not recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes Mellitus
• Fatty Liver
• Fatty Liver, Nonalcoholic
• Leaky Gut Syndrome
• Non-alcoholic Fatty Liver Disease
• Obesity
• Pancreatitis
• Pancreatitis, Chronic

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