Status:
COMPLETED
Intestinal Barrier Function and Probiotics.
Lead Sponsor:
TNO
Collaborating Sponsors:
VSL Pharmaceuticals
NIZO Food Research
Conditions:
Intestinal Permeability
Challenge Test
Eligibility:
MALE
21-40 years
Phase:
NA
Brief 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....
Detailed Description
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 sa...
Eligibility Criteria
Inclusion
- Healthy as assessed by the
- health and lifestyle questionnaire, (P9067 F02; in Dutch)
- physical examination
- results of the pre-study laboratory tests
- 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
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion
- Subjects with one or more of the following characteristics will be excluded from participation:
- 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
- Reported vegan, vegetarian or macrobiotic
- Not willing to be off working as a food handler, in child care or as a healthcare worker with direct patient contact during the week of ETEC contamination
- Not willing to give up blood donation during the study.
- Personnel of TNO Quality of Life, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01241201
Start Date
October 1 2010
End Date
December 1 2010
Last Update
July 21 2011
Active Locations (1)
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1
TNO Quality of Life
Zeist, Utrecht, Netherlands, 3704HE