Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480129
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2007-05-25
Brief Title:
The Anti-allergic Effects of Specific Probiotics
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
The Anti-allergic Effects of Specific Probiotics - a Double Blind Clinical Study
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesize that specifically selected probiotics can alleviate symptoms of allergy in lactose tolerant individuals Two strains of probiotics Lactobacillus rhamnosus GR-1 and Bifidobacterium adolescentis 7007-05 will be used to create a yogurt product Additionally a non-probiotic yogurt product will also be made as a placebo Allergy sufferers will be asked to consume one of the two types of yogurts blinded for two months During the two months there will be 3 sampling days for blood samples and nasal lavage samples Additionally Mini Rhinoconjunctivitis Quality of Life Questionnaires will be filled out weekly over the two months After the two months of perceived responses as well sample analysis we should have a better idea of how these specific probiotic effect the immune system and allergies
Detailed Description:
Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host Many studies have been performed which indicate that probiotics can temporarily modify the composition of gut microbiota and potentially these can reduce susceptibility to allergy Noverr Huffnagle 2005 Tannock et al 2000 leading to health benefits for the host Numerous studies show that these benefits include ones primed through the immune response of the host
Animals maintained free of microorganisms have drastic abnormalities in their immune response These germ-free animals have altered Peyers Patches reduced levels of IgA associated with increased risk for gastrointestinal infections and they are unable to develop oral tolerance to ingested antigens Moreau et al 1988 When these animals are later colonized by normal intestinal bacteria they overcome their past deficiencies and have a restored ability for oral tolerance This allows for the blockade of IgE production which is a key factor in allergic disease Moreau et al 1988
Studies on inflammatory bowel disease patients have shown that certain probiotics can actually reduce inflammation and diminish disease Bruzzese et al 2004 Baroja et al submitted The former study investigated 75 children while our study Baroja showed down regulation of inflammation in 820 inflammatory bowel diseased patients Allergic disease is almost non-existent in underdeveloped countries where interestingly fermented foods are consumed regularly This differs considerably from the numerous allergies and lack of fermented food intake in the Western World Investigators hypothesize that the human gut ecosystem has evolved to require daily intake of lactic acid bacteria Molin 2001 and these bacteria maintain immunological regulation which protects against allergic sensitization and development of allergic disease
Recent studies have shown that probiotics do have a significant influence on allergic reactions The consumption of Lactobacillus rhamnosus GG by pregnant women lowered the occurrence of babies born with atopic dermatitis compared to those births from women who had not consumed the probiotic Kalliomaki et al 2001 Another study on 27 infants suffering from atopic eczema showed that probiotic-supplemented formula decreased the severity of the condition Isolauri et al 2000 The efficacy of probiotics in treating allergy has been further shown with Bifidobacterium longum BB536 in which it relieved Japanese cedar tree pollinosis probably through the modulation of Th2-skewed immune response Xiao et al 2006 Another Japanese study showed that a synbiotic L casei subsp casei with dextran was an effective supplement for the prevention and treatment of allergic reactions cedar pollen Ogawa et al 2006 Not all studies have shown benefits and one performed in teenagers and young adults allergic to birch pollen and apple food showed no effect on intermittent symptoms of atopic allergy andor mild asthma We have now isolated strains of bifidobacteria from the stool of subjects with no history of any allergy and these along with two lactobacilli probiotics have shown strong anti-allergy potential in vitro In short there is evidence to indicate that studies are worthwhile using food based probiotics if not to completely prevent allergies but to contribute towards their alleviation
Objective 1 We will examine the cell types in nasal cavity with the expectation that this will shift as the probiotics are consumed with a decrease in number of eosinophils characteristic of late-phase allergic inflammatory symptoms as the study progresses and a corresponding decrease in neutrophils
Objective 2 We will characterize the subjects sensitivities to inhalant seasonal and potentially year-round allergens Routine RAST tests will be performed at the beginning of the study to test sensitivity towards mixed grasses mixed trees mixed weeds mixed molds ragweed house dust cat dander and dog dander From this we will be able to differentiate subjects who are highly susceptible to allergy and those moderately susceptible At the end of the trial we will perform further RAST tests using ragweed and mixed grass allergens with the anticipation that the probiotic treatment with anti-allergic strains will decrease the subjects sensitivity to those particular allergens while those receiving regular yogurt will have no effect
Objective 3 We will identify changes in serum cytokine levels that would indicate a shift from an inflammatory state to one of reduced inflammation We anticipate that the presence of inflammatory cytokines IL-5 IL-4 and IL-13 will be decreased as the subjects intestinal flora is boosted by the anti-allergic probiotics likewise the presence of anti-inflammatory cytokines IL-10 TGFβ2 IFN-γ will be increased by the treatment This shift in cytokine production should be reflected in reduced allergic symptoms In addition Affymetrix Human Genome U133 Plus 20 Arrays will be performed on selected blood samples to characterize immunological signal transduction pathways activated by the probiotic bacteria
Objective 4 We will characterize the perceived effects of anti-allergic strains of probiotics using a questionnaire Subjects will self-administer validated Mini Rhinoconjunctivitis Quality of Life Questionnaire MiniRQLQ Juniper et al 2000 on day 0 and weekly during the study period The questionnaire includes 14 questions in five domains activity limitations practical problems and nose symptoms eye symptoms and other symptoms The questions are answered on scale 0-6 from not troubled to extremely troubled depending how troubled the subjects have been due to their noseeye symptoms during the past week Possible lung symptoms cough dyspnoea and wheezing will be recorded separately using the same scale This perceived effect may actually be the single most important outcome to our study If the samples actually do show a decrease in inflammatory cytokines etc but the subject does not perceive any changes to their allergy symptoms then the probiotics cannot be stated to have affected the allergic response We hope that all shifts in cytokine and cellular levels towards the anti-inflammatory state are reflected in the subjects awareness of decreased allergy symptoms
At the end of this study we hope to know whether or not regular and probiotic yogurts have the potential to alleviate symptoms of allergic rhinitis as well as down regulate the inflammatory processes in humans It is anticipated that at least one of the yogurts will show promise in this regard However even a negative result would be informative as the experiments will show us how consumers respond physiologically to different fermented food
Animals maintained free of microorganisms have drastic abnormalities in their immune response These germ-free animals have altered Peyers Patches reduced levels of IgA associated with increased risk for gastrointestinal infections and they are unable to develop oral tolerance to ingested antigens Moreau et al 1988 When these animals are later colonized by normal intestinal bacteria they overcome their past deficiencies and have a restored ability for oral tolerance This allows for the blockade of IgE production which is a key factor in allergic disease Moreau et al 1988
Studies on inflammatory bowel disease patients have shown that certain probiotics can actually reduce inflammation and diminish disease Bruzzese et al 2004 Baroja et al submitted The former study investigated 75 children while our study Baroja showed down regulation of inflammation in 820 inflammatory bowel diseased patients Allergic disease is almost non-existent in underdeveloped countries where interestingly fermented foods are consumed regularly This differs considerably from the numerous allergies and lack of fermented food intake in the Western World Investigators hypothesize that the human gut ecosystem has evolved to require daily intake of lactic acid bacteria Molin 2001 and these bacteria maintain immunological regulation which protects against allergic sensitization and development of allergic disease
Recent studies have shown that probiotics do have a significant influence on allergic reactions The consumption of Lactobacillus rhamnosus GG by pregnant women lowered the occurrence of babies born with atopic dermatitis compared to those births from women who had not consumed the probiotic Kalliomaki et al 2001 Another study on 27 infants suffering from atopic eczema showed that probiotic-supplemented formula decreased the severity of the condition Isolauri et al 2000 The efficacy of probiotics in treating allergy has been further shown with Bifidobacterium longum BB536 in which it relieved Japanese cedar tree pollinosis probably through the modulation of Th2-skewed immune response Xiao et al 2006 Another Japanese study showed that a synbiotic L casei subsp casei with dextran was an effective supplement for the prevention and treatment of allergic reactions cedar pollen Ogawa et al 2006 Not all studies have shown benefits and one performed in teenagers and young adults allergic to birch pollen and apple food showed no effect on intermittent symptoms of atopic allergy andor mild asthma We have now isolated strains of bifidobacteria from the stool of subjects with no history of any allergy and these along with two lactobacilli probiotics have shown strong anti-allergy potential in vitro In short there is evidence to indicate that studies are worthwhile using food based probiotics if not to completely prevent allergies but to contribute towards their alleviation
Objective 1 We will examine the cell types in nasal cavity with the expectation that this will shift as the probiotics are consumed with a decrease in number of eosinophils characteristic of late-phase allergic inflammatory symptoms as the study progresses and a corresponding decrease in neutrophils
Objective 2 We will characterize the subjects sensitivities to inhalant seasonal and potentially year-round allergens Routine RAST tests will be performed at the beginning of the study to test sensitivity towards mixed grasses mixed trees mixed weeds mixed molds ragweed house dust cat dander and dog dander From this we will be able to differentiate subjects who are highly susceptible to allergy and those moderately susceptible At the end of the trial we will perform further RAST tests using ragweed and mixed grass allergens with the anticipation that the probiotic treatment with anti-allergic strains will decrease the subjects sensitivity to those particular allergens while those receiving regular yogurt will have no effect
Objective 3 We will identify changes in serum cytokine levels that would indicate a shift from an inflammatory state to one of reduced inflammation We anticipate that the presence of inflammatory cytokines IL-5 IL-4 and IL-13 will be decreased as the subjects intestinal flora is boosted by the anti-allergic probiotics likewise the presence of anti-inflammatory cytokines IL-10 TGFβ2 IFN-γ will be increased by the treatment This shift in cytokine production should be reflected in reduced allergic symptoms In addition Affymetrix Human Genome U133 Plus 20 Arrays will be performed on selected blood samples to characterize immunological signal transduction pathways activated by the probiotic bacteria
Objective 4 We will characterize the perceived effects of anti-allergic strains of probiotics using a questionnaire Subjects will self-administer validated Mini Rhinoconjunctivitis Quality of Life Questionnaire MiniRQLQ Juniper et al 2000 on day 0 and weekly during the study period The questionnaire includes 14 questions in five domains activity limitations practical problems and nose symptoms eye symptoms and other symptoms The questions are answered on scale 0-6 from not troubled to extremely troubled depending how troubled the subjects have been due to their noseeye symptoms during the past week Possible lung symptoms cough dyspnoea and wheezing will be recorded separately using the same scale This perceived effect may actually be the single most important outcome to our study If the samples actually do show a decrease in inflammatory cytokines etc but the subject does not perceive any changes to their allergy symptoms then the probiotics cannot be stated to have affected the allergic response We hope that all shifts in cytokine and cellular levels towards the anti-inflammatory state are reflected in the subjects awareness of decreased allergy symptoms
At the end of this study we hope to know whether or not regular and probiotic yogurts have the potential to alleviate symptoms of allergic rhinitis as well as down regulate the inflammatory processes in humans It is anticipated that at least one of the yogurts will show promise in this regard However even a negative result would be informative as the experiments will show us how consumers respond physiologically to different fermented food
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None