Intestinal Barrier Function and Probiotics.

NCT01241201 | Completed

• 1 other identifier: P9067
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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. 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

Keywords

intestinal health; probiotics; inflammation; biomarkers

Outcome Measures

Primary Outcomes (5)

• Faecal weight and mucus (diarrhoea)

  Characteristics of the faeces will be determined (% wet and dry weight)

  day 01

• Faecal weight and mucus (diarrhoea)

  Characteristics of the faeces will be determined (% wet and dry weight)

  day 20

• Faecal weight and mucus (diarrhoea)

  Characteristics of the faeces will be determined (% wet and dry weight)

  day 22

• Faecal weight and mucus (diarrhoea)

  Characteristics of the faeces will be determined (% wet and dry weight)

  day 23

• Faecal weight and mucus (diarrhoea)

  Characteristics of the faeces will be determined (% wet and dry weight)

  day 24

Secondary Outcomes (1)

• intestinal permeability

  day 01, 20 and day 22

Study Arms (1)

Placebo

PLACEBO COMPARATOR

placebo for probiotic treatment

Dietary Supplement: Priobiotic supplement VSL#3

Interventions

Priobiotic supplement VSL#3 DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TNO: lead
• VSL Pharmaceuticals: collaborator
• NIZO Food Research: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, Utrecht, 3704HE, Netherlands

Location

Related Publications (1)

• Bovee-Oudenhoven IM, Lettink-Wissink ML, Van Doesburg W, Witteman BJ, Van Der Meer R. Diarrhea caused by enterotoxigenic Escherichia coli infection of humans is inhibited by dietary calcium. Gastroenterology. 2003 Aug;125(2):469-76. doi: 10.1016/s0016-5085(03)00884-9.

  PMID: 12891550 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• W J Pasman, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

NL (1)