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

• Sponsor: University Hospital, Saarland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04067440
• Collaborator: Universität des Saarlandes (Other)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Diabetes Mellitus; Fatty Liver, Nonalcoholic; Leaky Gut Syndrome; Chronic Pancreatitis	Diagnostic Test: Microbial Swab

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

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Characterization and Comparison of the Human Microbiome in Peritoneum, Jejunum, Rectum and Stool
• Actual Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Characterization of microbiome [intra-operative]

   Previously uncharacterized sites: jejunum, peritoneum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• abdominal surgery containing opening of jejunum

• singing of consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,	Homburg/Saar		Germany	D-66421

Sponsors and Collaborators

• University Hospital, Saarland
• Universität des Saarlandes

Investigators

• Principal Investigator: Michael Jelden, Dr., Saarland University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Jelden, Dr. med. Michael Jelden, University Hospital, Saarland
• ClinicalTrials.gov Identifier: NCT04067440
• Other Study ID Numbers: METABIOM
• First Posted: Aug 26, 2019
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Jelden, Dr. med. Michael Jelden, University Hospital, Saarland: Microbiome; Obesity; Chronic Liver Disease
• Additional relevant MeSH terms: Fatty Liver; Pancreatitis; Pancreatitis, Chronic; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 9, 2022