The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers

NCT03021161 | Unknown Phase 4 DMC

• 1 other identifier: 548/2016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This project will be test the effect of probiotics on occupational allergic sensitization, respiratory symptoms and bronchial hyperresponsiveness in workers or students that develop respiratory symptoms exposed to laboratory animals, i.e., small rodents.

Conditions

Asthma Occupational

Keywords

probiotic

Outcome Measures

Primary Outcomes (1)

• detection the reduction of sensitization in workers exposed to laboratory animal

  To compare the effect of the oral administration of probiotics on the development of occupational sensitization to the effect of a placebo. Sensitization will be assessed by prick test and specific IgE.

  two years

Secondary Outcomes (1)

• Assessment of symptoms

  two years

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention group will receive once daily capsules containing 109 CFU of Lactobacillus rhamnosus HN001, Lactobacillus paracasei Lpc-37 and Bifidobacterium animalis ssp. Lactis HN019 (probiotic formula).

Drug: Probiotic Formula

Placebo Oral Capsule

PLACEBO COMPARATOR

The control group will receive once daily similar capsules containing placebo.

Other: Placebo Oral Capsule

Interventions

Probiotic Formula DRUG

The intervention group will receive once daily capsules containing 109 CFU of Lactobacillus rhamnosus HN001, Lactobacillus paracasei Lpc-37 and Bifidobacterium animalis ssp. Lactis HN019

Also known as: L. rhamnosus, L. paracasei, B. Lactis

intervention group

Placebo Oral Capsule OTHER

Capsule containing no probiotic

Also known as: Probiotic diluent

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years, both sexes, ability to read, understand and to decide on protocol consenting.
• Participants should be healthy
• Animal handling for research purposes as part of regular activities as a worker or student.
• Planning to continue this activity for the next 2 years.

You may not qualify if:

• Previous laboratory animal handling for 15 days or longer. This exposure may have sensitized or selected people that are not susceptible to sensitizations.
• Sensitization to any laboratory animal (rat, mouse, hamster, guinea pig or rabbit).
• Allergic diseases that interfere with the evaluation of study variables.
• Using immunosuppressive drugs (ex: methotrexate, cyclosporine, leflunomide) or corticosteroids in immunosuppressive doses (e.g.: prednisone doses of 1.0 mg/kg/day or more).
• Cancer or treatment of neoplasia.
• Having diseases that cause immunosuppression such as diabetes, AIDS, renal failure, heart failure or other organ failure.
• Pregnancy, breastfeeding, or not willing to take necessary precautions to avoid a pregnancy during the study.
• Use of other probiotic products during the study.

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (1)

University Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Related Publications (24)

• Curtin-Brosnan J, Paigen B, Hagberg KA, Langley S, O'Neil EA, Krevans M, Eggleston PA, Matsui EC. Occupational mouse allergen exposure among non-mouse handlers. J Occup Environ Hyg. 2010 Dec;7(12):726-34. doi: 10.1080/15459624.2010.530906.

  PMID: 21058157 BACKGROUND

• Ferraz E, Arruda LK, Bagatin E, Martinez EZ, Cetlin AA, Simoneti CS, Freitas AS, Martinez JA, Borges MC, Vianna EO. Laboratory animals and respiratory allergies: the prevalence of allergies among laboratory animal workers and the need for prophylaxis. Clinics (Sao Paulo). 2013 Jun;68(6):750-9. doi: 10.6061/clinics/2013(06)05.

  PMID: 23778494 BACKGROUND

• Fiocchi A, Pawankar R, Cuello-Garcia C, Ahn K, Al-Hammadi S, Agarwal A, Beyer K, Burks W, Canonica GW, Ebisawa M, Gandhi S, Kamenwa R, Lee BW, Li H, Prescott S, Riva JJ, Rosenwasser L, Sampson H, Spigler M, Terracciano L, Vereda-Ortiz A, Waserman S, Yepes-Nunez JJ, Brozek JL, Schunemann HJ. World Allergy Organization-McMaster University Guidelines for Allergic Disease Prevention (GLAD-P): Probiotics. World Allergy Organ J. 2015 Jan 27;8(1):4. doi: 10.1186/s40413-015-0055-2. eCollection 2015.

  PMID: 25628773 BACKGROUND

• Gandhi VD, Vliagoftis H. Airway epithelium interactions with aeroallergens: role of secreted cytokines and chemokines in innate immunity. Front Immunol. 2015 Apr 2;6:147. doi: 10.3389/fimmu.2015.00147. eCollection 2015.

  PMID: 25883597 BACKGROUND

• Gerrard JW, Geddes CA, Reggin PL, Gerrard CD, Horne S. Serum IgE levels in white and metis communities in Saskatchewan. Ann Allergy. 1976 Aug;37(2):91-100.

  PMID: 987744 BACKGROUND

• GLOBAL INITIATIVE FOR ASTHMA. Global strategy for asthma management and prevention 2014. <http://www.ginasthma.org/local/uploads/files/GINA_Report_2014_Jun11.pdf>.

  BACKGROUND

• Horwitch CA, Furseth HA, Larson AM, Jones TL, Olliffe JF, Spach DH. Lactobacillemia in three patients with AIDS. Clin Infect Dis. 1995 Dec;21(6):1460-2. doi: 10.1093/clinids/21.6.1460.

  PMID: 8749632 BACKGROUND

• Johansson SG, Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF, Motala C, Ortega Martell JA, Platts-Mills TA, Ring J, Thien F, Van Cauwenberge P, Williams HC. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004 May;113(5):832-6. doi: 10.1016/j.jaci.2003.12.591.

  PMID: 15131563 BACKGROUND

• Kalliomaki M, Kirjavainen P, Eerola E, Kero P, Salminen S, Isolauri E. Distinct patterns of neonatal gut microflora in infants in whom atopy was and was not developing. J Allergy Clin Immunol. 2001 Jan;107(1):129-34. doi: 10.1067/mai.2001.111237.

  PMID: 11150002 BACKGROUND

• Leynaert B, Neukirch C, Kony S, Guenegou A, Bousquet J, Aubier M, Neukirch F. Association between asthma and rhinitis according to atopic sensitization in a population-based study. J Allergy Clin Immunol. 2004 Jan;113(1):86-93. doi: 10.1016/j.jaci.2003.10.010.

  PMID: 14713912 BACKGROUND

• Petschow BW, Figueroa R, Harris CL, Beck LB, Ziegler E, Goldin B. Effects of feeding an infant formula containing Lactobacillus GG on the colonization of the intestine: a dose-response study in healthy infants. J Clin Gastroenterol. 2005 Oct;39(9):786-90. doi: 10.1097/01.mcg.0000177245.53753.86.

  PMID: 16145341 BACKGROUND

• Freitas AS, Simoneti CS, Ferraz E, Bagatin E, Brandao IT, Silva CL, Borges MC, Vianna EO. Exposure to high endotoxin concentration increases wheezing prevalence among laboratory animal workers: a cross-sectional study. BMC Pulm Med. 2016 May 6;16(1):69. doi: 10.1186/s12890-016-0233-1.

  PMID: 27153990 BACKGROUND

• Prescott SL, Bjorksten B. Probiotics for the prevention or treatment of allergic diseases. J Allergy Clin Immunol. 2007 Aug;120(2):255-62. doi: 10.1016/j.jaci.2007.04.027. Epub 2007 Jun 4.

  PMID: 17544096 BACKGROUND

• Simoneti CS, Freitas AS, Barbosa MC, Ferraz E, de Menezes MB, Bagatin E, Arruda LK, Vianna EO. Study of risk factors for atopic sensitization, asthma, and bronchial hyperresponsiveness in animal laboratory workers. J Occup Health. 2016;58(1):7-15. doi: 10.1539/joh.15-0045-OA. Epub 2015 Oct 20.

  PMID: 26490427 BACKGROUND

• Snydman DR. The safety of probiotics. Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S104-11; discussion S144-51. doi: 10.1086/523331.

  PMID: 18181712 BACKGROUND

• Tang ML, Lahtinen SJ, Boyle RJ. Probiotics and prebiotics: clinical effects in allergic disease. Curr Opin Pediatr. 2010 Oct;22(5):626-34. doi: 10.1097/MOP.0b013e32833d9728.

  PMID: 20733491 BACKGROUND

• Wang M, Karlsson C, Olsson C, Adlerberth I, Wold AE, Strachan DP, Martricardi PM, Aberg N, Perkin MR, Tripodi S, Coates AR, Hesselmar B, Saalman R, Molin G, Ahrne S. Reduced diversity in the early fecal microbiota of infants with atopic eczema. J Allergy Clin Immunol. 2008 Jan;121(1):129-34. doi: 10.1016/j.jaci.2007.09.011. Epub 2007 Oct 29.

  PMID: 18028995 BACKGROUND

• Wold AE. The hygiene hypothesis revised: is the rising frequency of allergy due to changes in the intestinal flora? Allergy. 1998;53(46 Suppl):20-5. doi: 10.1111/j.1398-9995.1998.tb04953.x. No abstract available.

  PMID: 9825991 BACKGROUND

• Wu CT, Chen PJ, Lee YT, Ko JL, Lue KH. Effects of immunomodulatory supplementation with Lactobacillus rhamnosus on airway inflammation in a mouse asthma model. J Microbiol Immunol Infect. 2016 Oct;49(5):625-635. doi: 10.1016/j.jmii.2014.08.001. Epub 2014 Nov 11.

  PMID: 25440975 BACKGROUND

• Abrahamsson TR, Jakobsson HE, Andersson AF, Bjorksten B, Engstrand L, Jenmalm MC. Low diversity of the gut microbiota in infants with atopic eczema. J Allergy Clin Immunol. 2012 Feb;129(2):434-40, 440.e1-2. doi: 10.1016/j.jaci.2011.10.025. Epub 2011 Dec 6.

  PMID: 22153774 RESULT

• Bantz SK, Zhu Z, Zheng T. The Atopic March: Progression from Atopic Dermatitis to Allergic Rhinitis and Asthma. J Clin Cell Immunol. 2014 Apr;5(2):202. doi: 10.4172/2155-9899.1000202.

  PMID: 25419479 RESULT

• Bisgaard H, Li N, Bonnelykke K, Chawes BL, Skov T, Paludan-Muller G, Stokholm J, Smith B, Krogfelt KA. Reduced diversity of the intestinal microbiota during infancy is associated with increased risk of allergic disease at school age. J Allergy Clin Immunol. 2011 Sep;128(3):646-52.e1-5. doi: 10.1016/j.jaci.2011.04.060. Epub 2011 Jul 22.

  PMID: 21782228 RESULT

• Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.

  PMID: 18331513 RESULT

• Bousquet J, Schunemann HJ, Zuberbier T, Bachert C, Baena-Cagnani CE, Bousquet PJ, Brozek J, Canonica GW, Casale TB, Demoly P, Gerth van Wijk R, Ohta K, Bateman ED, Calderon M, Cruz AA, Dolen WK, Haughney J, Lockey RF, Lotvall J, O'Byrne P, Spranger O, Togias A, Bonini S, Boulet LP, Camargos P, Carlsen KH, Chavannes NH, Delgado L, Durham SR, Fokkens WJ, Fonseca J, Haahtela T, Kalayci O, Kowalski ML, Larenas-Linnemann D, Li J, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Papadopoulos N, Passalacqua G, Rabe KF, Pawankar R, Ryan D, Samolinski B, Simons FE, Valovirta E, Yorgancioglu A, Yusuf OM, Agache I, Ait-Khaled N, Annesi-Maesano I, Beghe B, Ben Kheder A, Blaiss MS, Boakye DA, Bouchard J, Burney PG, Busse WW, Chan-Yeung M, Chen Y, Chuchalin AG, Costa DJ, Custovic A, Dahl R, Denburg J, Douagui H, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Kaliner MA, Keith PK, Kim YY, Klossek JM, Kuna P, Le LT, Lemiere C, Lipworth B, Mahboub B, Malo JL, Marshall GD, Mavale-Manuel S, Meltzer EO, Morais-Almeida M, Motala C, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Ouedraogo S, Palkonen S, Popov TA, Price D, Rosado-Pinto J, Scadding GK, Sooronbaev TM, Stoloff SW, Toskala E, van Cauwenberge P, Vandenplas O, van Weel C, Viegi G, Virchow JC, Wang DY, Wickman M, Williams D, Yawn BP, Zar HJ, Zernotti M, Zhong N; WHO Collaborating Center of Asthma and Rhinitis (Montpellier). Development and implementation of guidelines in allergic rhinitis - an ARIA-GA2LEN paper. Allergy. 2010 Oct;65(10):1212-21. doi: 10.1111/j.1398-9995.2010.02439.x.

  PMID: 20887423 RESULT

MeSH Terms

Conditions

Asthma, Occupational

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Occupational Diseases

Study Officials

• Elcio O Vianna, MD, PHD

  University of S. Paulo Medical School of Rib. Preto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elcio O Vianna, MD, PHD

CONTACT

55-16-36022706; evianna@fmrp.usp.br

Rosangela V Garcia, MD

CONTACT

55-16-36021800; rosangelavillela@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2020
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)