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Intestinal Barrier Function and Probiotics.

NCT01241201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-07-21

No results posted yet for this study

Summary

Rationale: Enterotoxigenic Escherichia coli (ETEC) bacteria adhere to the mucosa of the proximal intestines. There it produces an toxin which presents a local and relevant challenge to the intestines. This is proposed to give an indication of general resistance and/or the local resistance of the intestines. The sequel of events of mucosal inflammation will be characterized in this study. In addition we will evaluate the effects of probiotics by comparing the infection symptoms and by measuring faecal weight and mucus in faeces.

Objective: The main objective of this study is to investigate the effect of probiotics on the sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as total faecal output, relative faecal dry weight and mucin excretion in faeces. In addition, the sequels of the mucosal inflammation will be characterized and biomarkers will be searched.

Conditions

  • Intestinal Permeability
  • Challenge Test
  • Intestinal Health
  • Inflammation

Interventions

DIETARY_SUPPLEMENT

Priobiotic supplement VSL#3

four weeks, twice daily two sachets of VSL#3, a priobitics mixture

Sponsors & Collaborators

  • VSL Pharmaceuticals

    collaborator INDUSTRY

  • NIZO Food Research

    collaborator OTHER

  • TNO

    lead OTHER

Principal Investigators

  • W J Pasman, PhD · TNO

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT01241201 on ClinicalTrials.gov