The Anti-Allergic Effects of Specific Probiotics - Full Text View

Sponsors and Collaborators:	Lawson Health Research Institute Ontario Ministry of Agriculture, Food and Rural Affairs
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00480129

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Behavioral: Probiotic or placebo yogurt consumed daily Device: Mini Rhinoconjunctivitis Quality of Life Questionnaire Procedure: Blood sample Procedure: Nasal lavage	Phase I

MedlinePlus related topics: Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	The Anti-Allergic Effects of Specific Probiotics - a Double Blind Clinical Study

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Inflammatory versus anti-inflammatory serum cytokine fluctuations [ Time Frame: 2 months ]
Allergen specific IgE fluctuations [ Time Frame: 2 months ]
Type 2 T helper cell to Type 1 T helper cell ratios [ Time Frame: 2 months ]
T regulatory cell production of interleukin-10 [ Time Frame: 2 months ]
Cell count and type fluctuations in nasal lavage samples [ Time Frame: 2 months ]
Protein concentration fluctuations in nasal lavage samples [ Time Frame: 2 months ]

Secondary Outcome Measures:

Mini Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: 2 months ]

Enrollment:	36
Study Start Date:	May 2007
Study Completion Date:	October 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of allergic rhinitis based on sneeze attacks, runny/blocked/itchy nose in the absence of a common cold during the previous 12 months.
History of positive skin prick test or blood radio-allergosorbent test (RAST) to grass and/or ragweed pollen

Exclusion Criteria:

Ongoing allergen immunotherapy
upper respiratory tract infection
Pregnancy
Clinical history of lactose-intolerance or allergies to cow-milk

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480129

Locations

Canada, Ontario
Lawson Health Research Institute - Canadian Research and Development Centre for Probiotics
London, Ontario, Canada, N6A 4V2

Sponsors and Collaborators

Lawson Health Research Institute

Ontario Ministry of Agriculture, Food and Rural Affairs

Investigators

Principal Investigator:

Gregor Reid, PhD

Lawson Health Research Institute - Canadian Research and Development Centre for Probiotics

More Information

Publications:

Naclerio RM, Meier HL, Kagey-Sobotka A, Adkinson NF Jr, Meyers DA, Norman PS, Lichtenstein LM. Mediator release after nasal airway challenge with allergen. Am Rev Respir Dis. 1983 Oct;128(4):597-602.

Belda J, Parameswaran K, Keith PK, Hargreave FE. Repeatability and validity of cell and fluid-phase measurements in nasal fluid: a comparison of two methods of nasal lavage. Clin Exp Allergy. 2001 Jul;31(7):1111-5.

Bruzzese E, Raia V, Gaudiello G, Polito G, Buccigrossi V, Formicola V, Guarino A. Intestinal inflammation is a frequent feature of cystic fibrosis and is reduced by probiotic administration. Aliment Pharmacol Ther. 2004 Oct 1;20(7):813-9.

Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10.

Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9.

Moreau P, Paul P, Rouas-Freiss N, Kirszenbaum M, Dausset J, Carosella ED. Molecular and immunologic aspects of the nonclassical HLA class I antigen HLA-G: evidence for an important role in the maternal tolerance of the fetal allograft. Am J Reprod Immunol. 1998 Sep;40(3):136-44.

Ogawa T, Hashikawa S, Asai Y, Sakamoto H, Yasuda K, Makimura Y. A new synbiotic, Lactobacillus casei subsp. casei together with dextran, reduces murine and human allergic reaction. FEMS Immunol Med Microbiol. 2006 Apr;46(3):400-9.

Tannock GW, Munro K, Harmsen HJ, Welling GW, Smart J, Gopal PK. Analysis of the fecal microflora of human subjects consuming a probiotic product containing Lactobacillus rhamnosus DR20. Appl Environ Microbiol. 2000 Jun;66(6):2578-88.

Xiao JZ, Kondo S, Yanagisawa N, Takahashi N, Odamaki T, Iwabuchi N, Miyaji K, Iwatsuki K, Togashi H, Enomoto K, Enomoto T. Probiotics in the treatment of Japanese cedar pollinosis: a double-blind placebo-controlled trial. Clin Exp Allergy. 2006 Nov;36(11):1425-35.

Molin G. Probiotics in foods not containing milk or milk constituents, with special reference to Lactobacillus plantarum 299v. Am J Clin Nutr. 2001 Feb;73(2 Suppl):380S-385S. Review.

Noverr MC, Huffnagle GB. The 'microflora hypothesis' of allergic diseases. Clin Exp Allergy. 2005 Dec;35(12):1511-20. Review.

Study ID Numbers:	12885
Study First Received:	May 25, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00480129 History of Changes
Health Authority:	Canada: University of Western Ontario Health Science Research Ethics Board; Canada: Ontario Ministry of Agriculture, Food and Rural Affairs

Keywords provided by Lawson Health Research Institute:

grass allergies,
ragweed allergies,
probiotics, lactobacillus,
bifidobacterium,

functional foods,
yogurt,
inflammatory cytokines

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Rhinitis
Anti-Allergic Agents

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses

Rhinitis
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on May 07, 2009