The Anti-allergic Effects of Specific Probiotics

NCT00480129 | Completed Phase 1

• 1 other identifier: 12885
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

grass allergies,; ragweed allergies,; probiotics, lactobacillus,; bifidobacterium,; functional foods,; yogurt,; inflammatory cytokines

Outcome Measures

Primary Outcomes (6)

• Inflammatory versus anti-inflammatory serum cytokine fluctuations

  2 months

• Allergen specific IgE fluctuations

  2 months

• Type 2 T helper cell to Type 1 T helper cell ratios

  2 months

• T regulatory cell production of interleukin-10

  2 months

• Cell count and type fluctuations in nasal lavage samples

  2 months

• Protein concentration fluctuations in nasal lavage samples

  2 months

Secondary Outcomes (1)

• Mini Rhinoconjunctivitis Quality of Life Questionnaire

  2 months

Interventions

Probiotic or placebo yogurt consumed daily BEHAVIORAL

Mini Rhinoconjunctivitis Quality of Life Questionnaire DEVICE

Blood sample PROCEDURE

Nasal lavage PROCEDURE

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ontario Ministry of Agriculture, Food and Rural Affairs: collaborator

Study Sites (1)

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

London, Ontario, N6A 4V2, Canada

Location

Related Publications (12)

• 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. doi: 10.1093/ajcn/73.2.380s.

  PMID: 11157345 BACKGROUND

• Noverr MC, Huffnagle GB. The 'microflora hypothesis' of allergic diseases. Clin Exp Allergy. 2005 Dec;35(12):1511-20. doi: 10.1111/j.1365-2222.2005.02379.x.

  PMID: 16393316 BACKGROUND

• 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. doi: 10.1164/arrd.1983.128.4.597.

  PMID: 6354022 RESULT

• 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. doi: 10.1046/j.1365-2222.2001.01133.x.

  PMID: 11468003 RESULT

• 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. doi: 10.1111/j.1365-2036.2004.02174.x.

  PMID: 15379842 RESULT

• 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. doi: 10.1046/j.1365-2222.2000.00943.x.

  PMID: 11069570 RESULT

• 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. doi: 10.1016/S0140-6736(00)04259-8.

  PMID: 11297958 RESULT

• 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. doi: 10.1111/j.1600-0897.1998.tb00405.x.

  PMID: 9764357 RESULT

• 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. doi: 10.1111/j.1574-695X.2006.00046.x.

  PMID: 16553814 RESULT

• 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. doi: 10.1128/AEM.66.6.2578-2588.2000.

  PMID: 10831441 RESULT

• 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. doi: 10.1111/j.1365-2222.2006.02575.x.

  PMID: 17083353 RESULT

• Koyama T, Kirjavainen PV, Fisher C, Anukam K, Summers K, Hekmat S, Reid G. Development and pilot evaluation of a novel probiotic mixture for the management of seasonal allergic rhinitis. Can J Microbiol. 2010 Sep;56(9):730-8. doi: 10.1139/w10-061.

  PMID: 20921983 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Probiotics; Blood Specimen Collection; Nasal Lavage

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutic Irrigation

Study Officials

• Gregor Reid, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 30, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

CA (1)