Intestinal Barrier Function and Probiotics. (NCT01241201) | Clinical Trial Compass
CompletedNot Applicable
Intestinal Barrier Function and Probiotics.
Netherlands32 participantsStarted 2010-10
Plain-language 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.
Who can participate
Age range21 Years – 40 Years
SexMALE
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Inclusion criteria
✓. Healthy as assessed by the
✓. Males, Age \>= 21 and \<= 40 years at Day 01 of the study
✓. Body Mass Index (BMI) \>= 20 and \< 33 kg/m2. Preferably in high and low body fat mass ranges as to be determined by waist circumference
✓. Normal Dutch eating habits as assessed by P9067 F02
✓. Voluntary participation
✓. Having given written informed consent
✓. Willing to comply with the study procedures, including the ETEC challenge
✓. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
Exclusion criteria
✕. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
✕. Having a history of medical or surgical events that may significantly affect the study outcome, including gastrointestinal illness or surgical operations,
✕. Use of antibiotics, immunosuppressive drugs, antacids, laxatives or anti-diarrhoeal drugs in the last 3 months before the study
✕. Alcohol consumption \> 28 units/week for males
✕. Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
✕. Reported slimming or medically prescribed diet