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Effects of Nutritional Fat on the Growth of Intestinal E. Coli

NCT03800147 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-01-11

No results posted yet for this study

Summary

Recent experiments in the lab of Prof. WD Hardt revealed, that in mice, 24 h exposure to a high-fat diet results in a breakdown of colonization resistance against Salmonella typhimurium. Mechanistic experiments identified bile acids as the mediator for reduced colonization resistance. Exposure to a high fat diet leads to increased bile acid secretion which in turn modify the intestinal microbiota.

It is now the aim to verify the results of this study in human healthy volunteers. The nutritional habits of all participants will carefully be evaluated. In the intervention phase, participants will be exposed to either high-fat or low-fat diet and a controlled dose of the non-pathogenic bacteria E. coli Nissle. E. coli Nissle is the active compound for "Mutaflor®" and other probiotics.

It is planned to enumerate E. coli Nissle counts in the stool after Mutaflor ingestion and to quantify other changes of the human microbiota. The hypothesis is that a high-fat diet leads to increased bile acid secretion results in favorable growth conditions for E. coli Nissle, resulting in high bacterial counts in the stool.

Conditions

  • Escherichia Coli Infections

Interventions

DRUG

"Mutaflor Suspension" (E. coli Nissle 1917)

Inoculation of "Mutaflor Suspension" (E. coli Nissle 1917)

OTHER

Blood samples

Blood samples will be collected and analyzed at different study time points

OTHER

Stool samples

Stool samples will be collected and analyzed at different study time points

OTHER

Clinical information

Clinical information will be collected at different study time points using questionnaires

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Wolf-Dietrich Hardt, Prof. Dr. · ETH Zurich, Institute of Microbiology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2019-09-24
Completion
2019-09-24

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800147 on ClinicalTrials.gov