High-fat Diet (HFD) and Small Intestinal Microbiome

NCT07019142 | Completed

• 1 other identifier: 2020-02116
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to characterize the upper small intestinal microbiome in healthy conditions in dependency on feeding condition (starved vs. high-fat-challenged) and diet (before and after 3 day high-fat-diet) Primary outcome will be the maximum culturable bacteria (aerobic and anaerobic) in small intestinal luminal content during acute liquid-fat challenge before vs. after a short-term (3 day) high-fat-diet In this pilot study, healthy volunteers will undergo i) an upper endoscopy for harvesting of small intestinal juice, mucosal biopsies and ii) blood withdrawal at baseline (starved) as well as during acute one-time high-fat luminal stimulation (within 3 hours after baseline) utilizing microbiological culture and 16S-RNA sequencing. The same procedure will be performed after 3 day high-fat-diet. During endoscopy an acute luminal high-fat challenge which will be repeated after a short-term (3 day) high-fat diet

Conditions

Microbial Colonization; Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (1)

• Culturable bacteria

  Maximum culturable bacteria (aerobic and anaerobic) in small intestinal luminal content during acute liquid-fat challenge before vs. after a short-term (3 day) high-fat-diet

  3 days

Study Arms (1)

HFD-challenge

OTHER

Luminal application of liquid fat

Dietary Supplement: HFD

Interventions

HFD DIETARY_SUPPLEMENT

Luminal challenge with standardized volume, amount, calories of fat

HFD-challenge

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Adults ≥18 years of age
• BMI between 18.5 and 25 kg/m2

You may not qualify if:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
• Define drugs not allowed during the study or for specific periods of time prior to the administration of the test dose,
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons,
• inability or unwillingness to provide blood samples and tissue samples (biopsies),
• Participants taking oral anticoagulant or with bleeding disorders who would be at much higher risk of bleeding after biopsy samples or who are contraindicated for an endoscopic examination,
• Uncertain diagnosis, non-resident patients and patients unable to give informed consent
• Patients that undergo chemotherapeutic treatment,
• Patients that have been under antibiotic therapy in the last 4 weeks,

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 healthy volunteers with descriptive assessment of Primary endpoint

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: June 13, 2025
• Study Start: March 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: November 1, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)