Gastro Intestinal InfectionNCT01456767
Effects of Administration of L.Plantarum WCFS1, L.Plantarum CIP104448, L.Plantarum CIP104450 on Small Intestinal Mucosa
A study testing Probiotics in people with Gastro Intestinal Infection, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The design of this study conforms to a randomized double-blind placebo-controlled cross-over design. The objective of the study is to assess the effect of three probiotics (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) on intestinal epithelial permeability and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro Intestinal Infection
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to Apr 2012
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years.
- BMI between 20 and 30 kg/m2.
Who cannot join
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing.
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator).
- Pregnancy, lactation.
- Excessive alcohol consumption (>20 alcoholic consumptions per week).
Show all 11Show fewer
- Smoking.
- Blood donation within 3 months before or after the study period.
- Self-admitted HIV-positive state.
- Known hypersensitivity or history of allergic reactions towards intake of non-steroidal anti-inflammatory drugs (NSAIDs) or non- or low caloric sweeteners of any kind.
- History of any side effects towards intake of pro- or prebiotic supplements of any kind.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Health, Medicine and Life Sciences
Maastricht, Limburg, 6200 MD
About this study
Official title: The Effects of Oral Administration of Lactobacillus Plantarum WCFS1, Lactobacillus Plantarum CIP104448, and Lactobacillus Plantarum CIP104450 on Small Intestinal Mucosa and Barrier Function
The design of this study conforms to a randomized double-blind placebo-controlled cross-over design.
The objective of the study is to assess the effect of three probiotics (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) on intestinal epithelial permeability and the immune system, in at least 8 healthy subject.
Read more
The effect of the three different probiotics and a placebo will be assessed on every subject in random sequence.
Prior to the start of a 7-days supplementation period (one of the three probiotic supplements or placebo), blood samples will be obtained and small intestinal permeability will be assessed by measuring the urinary extraction ratios of ingested water-soluble, non-degradable test probes, with and without indomethacin challenge (to compromise the gut). After each supplementation period the gut will be stressed again by the indomethacin protocol, followed by measurement of small intestinal permeability, whereupon blood samples will be taken and duodenal tissue samples will be obtained by standard gastroduodenoscopy. Each supplementation period will start 1 month after finishing the pervious test episode, in randomized sequence.
The primary objective of this study is to assess the effects of Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on intestinal epithelial permeability. Secondary objectives are to assess the effects on immune modulation, gene expression of peripheral blood mononuclear cells, small intestine epithelial gene regulation and tight junction proteins modulation, infiltration of immune cells in intestinal mucosa and immune markers in blood plasma.
The investigators hypothesize that Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 will, each separately, significantly affect the innate immune system and intestinal permeability in humans.
- Conditions
- Gastro Intestinal Infection
- Being tested
- Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Bacterial supplements (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) will be prepared in the food-grade pilot plant of NIZO food research. Exactly 1x10^11 life bacteria are consumed by each participant.
Consumption of this amount of life bacteria is in line with earlier human studies and routinely reached by the consumption of dairy. As a placebo, the same drink will be used without addition of bacterial cells.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum WCFS1 | Active comparator | Al study subjects will in randomized sequence participate in this arm (7-days supplementation period of Lactobacillus plantarum WCFS1).
Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. Receives: Dietary Supplement: Probiotics |
| Lactobacillus plantarum CIP104448 | Active comparator | Al study subjects will in randomized sequence participate in this arm (7-days supplementation period of Lactobacillus plantarum CIP104448).
Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. Receives: Dietary Supplement: Probiotics |
| Lactobacillus plantarum CIP104450 | Active comparator | Al study subjects will in randomized sequence participate in this arm (7-days supplementation period of Lactobacillus plantarum CIP104450).
Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Al study subjects will in randomized sequence participate in this arm (7-days supplementation period of a placebo).
Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sugar recovery in urine, as indicator of intestinal permeability, after seven days probiotics supplementation.
The barrier function test is based on a comparison of intestinal permeation of a larger molecule with that of a smaller molecule. The subject will ingest a sugar drink containing sucrose, lactulose, L-rhamnose, sucralose and erythritol after an overnight fast. All sugar probes are accepted and validated parameters of integrity of the intestinal barrier, and proved an accurate estimation of mucosal damage.
Urine samples will be obtained to measure sugar recovery. The sugar molecules will be determined by fluorescent detection high-pressure liquid chromatography (HPLC).
Measured: Permeability will be assessed at baseline (3 days before supplementation), at baseline after indomethacin administration (1 day before supplementation) and after the 7-days probiotics supplementation period (again after indomethacin administration).
Secondary outcomes (2)
Differences of measurements in duodenal biopsy specimens between the separate arms.
- Tight junction proteins with immunofluorescent labelling and PCR quantification of perijunctional actin, myosin, ZO-1, claudin-3, occludin, myosin light chain kinase, and phosphorylated myosin light chain
- Transcriptomics: Affymetrix genome-wide microarrays, Validation and semi-quantification of selected genes by qPCR
- Markers of immune activation: Infiltration of immune cells by immunofluorescent staining
- Biochemical analysis of myeloperoxidase (MPO)
Measured: Duodenal biopsy specimens will be obtained at the end of each probiotics supplementation period (one day after the seven day supplementation).
Change in measurements in whole blood, after the seven days probiotics supplementation period.
- Quantify immune cell populations (T helper cells, cytotoxic T cells, CD25+ effector T cells, CD69+ effector T cells, regulatory T cells, and NK-cells)
- Biomarkers of immune stimulation (the human cytokines IL-10, TGF-β, IL-12p40 subunit, IL-12p70 subunit, IL-1β, IL-2, IL-6, IL-4, IL-17, IL-22 and IFN-γ, TNFα)
- Transcriptomics on peripheral blood mononuclear cells: affymetrix genome-wide microarrays, validation and semi-quantification of selected genes by qPCR
Measured: Measurements in whole blood will be carried out at baseline (3 days before supplementation) and after the 7-days probiotics supplementation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Intestinal InfectionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ad Masclee, Prof. dr., Principal investigator, Maastricht University Medical CenterFreddy Troost, Dr., Principal investigator, Maastricht University Medical CenterZlatan Mujagic, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456767
- Sponsor's protocol ID
- NL35728.068.11/METC11-2-011
- Status last verified
- Jul 2012
- First submitted
- 10 Oct 2011
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Administration of Lactobacillus Plantarum WCFS1, Lactobacillus Plantarum CIP104448, and Lactobacillus Plantarum CIP104450 on Small Intestinal Mucosa and Barrier Function
- ClinicalTrials.gov ID
- NCT01456767
- Acronym / sponsor ID
- NL35728.068.11/METC11-2-011
- Conditions
- Gastro Intestinal Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- First posted
- 21 Oct 2011 (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.
The design of this study conforms to a randomized double-blind placebo-controlled cross-over design.
The objective of the study is to assess the effect of three probiotics (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) on intestinal epithelial permeability and the immune system, in at least 8 healthy subject.
The effect of the three different probiotics and a placebo will be assessed on every subject in random sequence.
Prior to the start of a 7-days supplementation period (one of the three probiotic supplements or placebo), blood samples will be obtained and small intestinal permeability will be assessed by measuring the urinary extraction ratios of ingested water-soluble, non-degradable test probes, with and without indomethacin challenge (to compromise the gut). After each supplementation period the gut will be stressed again by the indomethacin protocol, followed by measurement of small intestinal permeability, whereupon blood samples will be taken and duodenal tissue samples will be obtained by standard gastroduodenoscopy. Each supplementation period will start 1 month after finishing the pervious test episode, in randomized sequence.
The primary objective of this study is to assess the effects of Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on intestinal epithelial permeability. Secondary objectives are to assess the effects on immune modulation, gene expression of peripheral blood mononuclear cells, small intestine epithelial gene regulation and tight junction proteins modulation, infiltration of immune cells in intestinal mucosa and immune markers in blood plasma.
The investigators hypothesize that Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 will, each separately, significantly affect the innate immune system and intestinal permeability in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum WCFS1 | Active comparator | Dietary Supplement: ProbioticsAl study subjects will in randomized sequence participate in this arm (7-days supplementation period of Lactobacillus plantarum WCFS1). Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. |
| Lactobacillus plantarum CIP104448 | Active comparator | Dietary Supplement: ProbioticsAl study subjects will in randomized sequence participate in this arm (7-days supplementation period of Lactobacillus plantarum CIP104448). Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. |
| Lactobacillus plantarum CIP104450 | Active comparator | Dietary Supplement: ProbioticsAl study subjects will in randomized sequence participate in this arm (7-days supplementation period of Lactobacillus plantarum CIP104450). Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. |
| Placebo | Placebo comparator | Dietary Supplement: ProbioticsAl study subjects will in randomized sequence participate in this arm (7-days supplementation period of a placebo). Each arm represents a 7-days supplementation period (with probiotics or placebo). The 7-days supplementation period will be followed by a month washout time after which the next supplementation period with another probiotic (or placebo) will start. The sequence is randomized and double blind. The different measurements will be performed at baseline and after each supplementation period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years.
- BMI between 20 and 30 kg/m2.
Key exclusion criteria (11 listed)
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing.
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator).
- Pregnancy, lactation.
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 |
|---|---|---|
| ProbioticsBacterial supplements (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) will be prepared in the food-grade pilot plant of NIZO food research. Exactly 1x10^11 life bacteria are consumed by each participant. Consumption of this amount of life bacteria is in line with earlier human studies and routinely reached by the consumption of dairy. As a placebo, the same drink will be used without addition of bacterial cells. | Dietary supplement | Lactobacillus plantarum CIP104448, Lactobacillus plantarum CIP104450, Lactobacillus plantarum WCFS1, Placebo |
Primary outcome
Change in sugar recovery in urine, as indicator of intestinal permeability, after seven days probiotics supplementation.
Time frame: Permeability will be assessed at baseline (3 days before supplementation), at baseline after indomethacin administration (1 day before supplementation) and after the 7-days probiotics supplementation period (again after indomethacin administration).
The barrier function test is based on a comparison of intestinal permeation of a larger molecule with that of a smaller molecule. The subject will ingest a sugar drink containing sucrose, lactulose, L-rhamnose, sucralose and erythritol after an overnight fast. All sugar probes are accepted and validated parameters of integrity of the intestinal barrier, and proved an accurate estimation of mucosal damage. Urine samples will be obtained to measure sugar recovery. The sugar molecules will be determined by fluorescent detection high-pressure liquid chromatography (HPLC).
2 secondary outcomes
Differences of measurements in duodenal biopsy specimens between the separate arms.
Time frame: Duodenal biopsy specimens will be obtained at the end of each probiotics supplementation period (one day after the seven day supplementation).
Change in measurements in whole blood, after the seven days probiotics supplementation period.
Time frame: Measurements in whole blood will be carried out at baseline (3 days before supplementation) and after the 7-days probiotics supplementation period.
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 19 Jul 2012.
Related trials for Gastro Intestinal Infection
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
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.
Ad Masclee, Prof. dr. principal investigator
Maastricht University Medical Center
Freddy Troost, Dr. principal investigator
Maastricht University Medical Center
Zlatan Mujagic principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Gastro Intestinal Infection, run by Maastricht University Medical Center 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 3 inclusion and 11 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 19 Jul 2012. 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?
Change in sugar recovery in urine, as indicator of intestinal permeability, after seven days probiotics supplementation. (time frame: Permeability will be assessed at baseline (3 days before supplementation), at baseline after indomethacin administration (1 day before supplementation) and after the 7-days probiotics supplementation period (again after indomethacin administration).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2012.