Effects of Administration of L.Plantarum WCFS1, L.Plantarum CIP104448, L.Plantarum CIP104450 on Small Intestinal Mucosa
NCT ID: NCT01456767
Last Updated: 2012-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2011-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Lactobacillus plantarum WCFS1
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.
Probiotics
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.
Lactobacillus plantarum CIP104448
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.
Probiotics
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.
Lactobacillus plantarum CIP104450
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.
Probiotics
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.
Placebo
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.
Probiotics
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.
Interventions
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Probiotics
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.
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 65 years.
* BMI between 20 and 30 kg/m2.
Exclusion Criteria
* 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).
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ad Masclee, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Freddy Troost, Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Zlatan Mujagic
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Health, Medicine and Life Sciences
Maastricht, Limburg, Netherlands
Countries
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Other Identifiers
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NL35728.068.11/METC11-2-011
Identifier Type: -
Identifier Source: org_study_id