NCT04067440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

3.8 years

First QC Date

August 21, 2019

Last Update Submit

May 22, 2025

Conditions

ObesityDiabetes MellitusFatty Liver, NonalcoholicLeaky Gut SyndromeChronic Pancreatitis

Keywords

MicrobiomeObesityChronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Characterization of microbiome

    Previously uncharacterized sites: jejunum, peritoneum

    intra-operative

Study Arms (1)

Patients

Subjects to undergo surgery including opening of the jejunum with non-inflammative condition.

Diagnostic Test: Microbial Swab

Interventions

Microbial SwabDIAGNOSTIC_TEST

Swabs will be taken from peritoneum and jejunum (intraoperatively), rectum, and stool

Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with obesity

You may qualify if:

  • abdominal surgery containing opening of jejunum
  • singing of consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,

Homburg/Saar, D-66421, Germany

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusNon-alcoholic Fatty Liver DiseasePancreatitis, Chronic

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System DiseasesPancreatitisPancreatic DiseasesChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Michael Jelden, Dr.

    Saarland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Michael Jelden

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

October 1, 2019

Primary Completion

July 30, 2023

Study Completion

July 30, 2024

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

DE(1)