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Intestinal Barrier Function and Probiotics.

Primary Purpose

Intestinal Permeability, Challenge Test, Intestinal Health

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Priobiotic supplement VSL#3

About this trial

This is an interventional basic science trial for Intestinal Permeability focused on measuring intestinal health, probiotics, inflammation, biomarkers

Eligibility Criteria

21 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

TNO Quality of Life

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

Placebo

Arm Description

placebo for probiotic treatment

Outcomes

Primary Outcome Measures

Faecal weight and mucus (diarrhoea)

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

Faecal weight and mucus (diarrhoea)

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

Faecal weight and mucus (diarrhoea)

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

Faecal weight and mucus (diarrhoea)

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

Faecal weight and mucus (diarrhoea)

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

Secondary Outcome Measures

intestinal permeability

Determine the intestinal permeability before and after probiotic supplementation and especially after infection of the intestines.

Full Information

NCT ID

NCT01241201

First Posted

October 29, 2010

Last Updated

July 20, 2011

Sponsor

TNO

Collaborators

VSL Pharmaceuticals, NIZO Food Research

1. Study Identification

Unique Protocol Identification Number

NCT01241201

Brief Title

Intestinal Barrier Function and Probiotics.

Official Title

A Study Proposal to Investigate the Sequels of Mucosal Inflammation Caused by ETEC Infection - the Effects of Probiotics.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

TNO

Collaborators

VSL Pharmaceuticals, NIZO Food Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intestinal Permeability, Challenge Test, Intestinal Health, Inflammation

Keywords

intestinal health, probiotics, inflammation, biomarkers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo for probiotic treatment

Intervention Type

Dietary Supplement

Intervention Name(s)

Priobiotic supplement VSL#3

Intervention Description

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

Primary Outcome Measure Information:

Title

Faecal weight and mucus (diarrhoea)

Description

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

Time Frame

day 01

Title

Faecal weight and mucus (diarrhoea)

Description

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

Time Frame

day 20

Title

Faecal weight and mucus (diarrhoea)

Description

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

Time Frame

day 22

Title

Faecal weight and mucus (diarrhoea)

Description

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

Time Frame

day 23

Title

Faecal weight and mucus (diarrhoea)

Description

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

Time Frame

day 24

Secondary Outcome Measure Information:

Title

intestinal permeability

Description

Determine the intestinal permeability before and after probiotic supplementation and especially after infection of the intestines.

Time Frame

day 01, 20 and day 22

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

W J Pasman, PhD

Organizational Affiliation

TNO

Official's Role

Principal Investigator

Facility Information:

Facility Name

TNO Quality of Life

City

Zeist

State/Province

Utrecht

ZIP/Postal Code

3704HE

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

12891550

Citation

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.

Results Reference

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Intestinal Barrier Function and Probiotics.

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