Intestinal Barrier Function and Probiotics.
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|ClinicalTrials.gov Identifier: NCT01241201|
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : July 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Permeability Challenge Test Intestinal Health Inflammation||Dietary Supplement: Priobiotic supplement VSL#3||Not Applicable|
Study population: 36 Healthy male volunteers; age >= 21 and <= 40 years. Intervention: One group receives twice daily two sachets containing 450 billion live freeze-dried lactic acid bacteria per sachet and the other group receives twice daily two placebo sachets.
Study design: The study is designed as a randomized, parallel, placebo-controlled, double-blind study. Study substance (probiotics) and placebo will be given during 4 weeks.
Main study parameters/endpoints: The main study parameter is the percent change in faecal dry weight and total faecal output between the probiotics group and the placebo group. In addition, intestinal permeability, inflammation and other clinical symptoms will be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study healthy male volunteers will be challenged with an attenuated ETEC strain after three weeks of either probiotics or placebo. This infection will lead to a mild traveller's diarrhoea in the subjects during approximately three days maximally. Sequels of this infection and the effects of commercially available probiotics compared to placebo will be followed up. The subjects will therefore collect their faeces on several days, record their defecation pattern and gastro-intestinal complaints during four weeks, undergo a physical examination and five venapunctions, and visit our facilities in total on 8 days (excluding two pre-study visits). The oral administration of probiotics in a healthy population is not associated with risk.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study Proposal to Investigate the Sequels of Mucosal Inflammation Caused by ETEC Infection - the Effects of Probiotics.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Placebo Comparator: Placebo
placebo for probiotic treatment
Dietary Supplement: Priobiotic supplement VSL#3
four weeks, twice daily two sachets of VSL#3, a priobitics mixture
- Faecal weight and mucus (diarrhoea) [ Time Frame: day 01 ]Characteristics of the faeces will be determined (% wet and dry weight)
- Faecal weight and mucus (diarrhoea) [ Time Frame: day 20 ]Characteristics of the faeces will be determined (% wet and dry weight)
- Faecal weight and mucus (diarrhoea) [ Time Frame: day 22 ]Characteristics of the faeces will be determined (% wet and dry weight)
- Faecal weight and mucus (diarrhoea) [ Time Frame: day 23 ]Characteristics of the faeces will be determined (% wet and dry weight)
- Faecal weight and mucus (diarrhoea) [ Time Frame: day 24 ]Characteristics of the faeces will be determined (% wet and dry weight)
- intestinal permeability [ Time Frame: day 01, 20 and day 22 ]Determine the intestinal permeability before and after probiotic supplementation and especially after infection of the intestines.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241201
|TNO Quality of Life|
|Zeist, Utrecht, Netherlands, 3704HE|
|Principal Investigator:||W J Pasman, PhD||TNO|