Intestinal PermeabilityNCT01241201
Intestinal Barrier Function and Probiotics.
A study testing Priobiotic supplement VSL#3 in people with Intestinal Permeability and Challenge Test, run by TNO at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intestinal Permeability, Challenge Test, Intestinal Health
- What is being tested?
- Priobiotic supplement VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Proposal to Investigate the Sequels of Mucosal Inflammation Caused by ETEC Infection - the Effects of Probiotics.
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.
Read the 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.
- Being tested
- Priobiotic supplement VSL#3
- Keywords
- intestinal health, probiotics, inflammation, biomarkers
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Priobiotic supplement VSL#3Dietary supplement
four weeks, twice daily two sachets of VSL#3, a priobitics mixture
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo for probiotic treatment Receives: Dietary Supplement: Priobiotic supplement VSL#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal weight and mucus (diarrhoea)
Characteristics of the faeces will be determined (% wet and dry weight)
Measured: day 01
Faecal weight and mucus (diarrhoea)
Characteristics of the faeces will be determined (% wet and dry weight)
Measured: day 20
Faecal weight and mucus (diarrhoea)
Characteristics of the faeces will be determined (% wet and dry weight)
Measured: day 22
Faecal weight and mucus (diarrhoea)
Characteristics of the faeces will be determined (% wet and dry weight)
Measured: day 23
Faecal weight and mucus (diarrhoea)
Characteristics of the faeces will be determined (% wet and dry weight)
Measured: day 24
Secondary outcomes (1)
intestinal permeability
Determine the intestinal permeability before and after probiotic supplementation and especially after infection of the intestines.
Measured: day 01, 20 and day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal PermeabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- VSL Pharmaceuticals, NIZO Food Research
- Investigators
- W J Pasman, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241201
- Sponsor's protocol ID
- P9067
- Status last verified
- Jul 2011
- First submitted
- 29 Oct 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12891550
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Proposal to Investigate the Sequels of Mucosal Inflammation Caused by ETEC Infection - the Effects of Probiotics.
- ClinicalTrials.gov ID
- NCT01241201
- Acronym / sponsor ID
- P9067
- Keywords
- intestinal health, probiotics, inflammation, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- VSL Pharmaceuticals, NIZO Food Research
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Priobiotic supplement VSL#3placebo for probiotic treatment |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Priobiotic supplement VSL#3four weeks, twice daily two sachets of VSL#3, a priobitics mixture | Dietary supplement | Placebo |
Primary outcome
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)
1 secondary outcome
intestinal permeability
Time frame: day 01, 20 and day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
- Background: PubMed 12891550Bovee-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W J Pasman, PhD principal investigator
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Priobiotic supplement VSL#3 in people with Intestinal Permeability and Challenge Test, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal weight and mucus (diarrhoea) (time frame: day 01). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.