Asthma OccupationalPhase 4prob&asthmaNCT03021161
The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers
A Phase 4 study testing Probiotic Formula in people with Asthma Occupational, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma Occupational
- What is being tested?
- Probiotic Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Hospital of Ribeirao Preto
Ribeirão Preto, São Paulo, 14048900
Elcio O Vianna, MD, PHD, 55-16-3602-2706, evianna@fmrp.usp.br
Rosangela V Garcia, MD, 55-16-36021800, rosangelavillela@yahoo.com.br
About this study
Official title: The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers: A Randomized Controlled Trial.
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.
Read the detailed description
INTRODUCTION: The objective of the present project is to test the effect of probiotics on occupational allergic sensitization, respiratory symptoms and bronchial hyperresponsiveness in workers or students exposed to laboratory animals, i.e., small rodents.
Furthermore, our study aims to determine changes in immunological patterns with the use of probiotics in adulthood, which could prevent allergic sensitization and allergic diseases.
Probiotics have been used as treatment in various allergic diseases, especially as prevention of child atopic dermatitis by using them during pregnancy, or for neonates and infants.
STUDY DESIGN AND METHODS: This will be a randomized controlled trial involving laboratory animal workers and students exposed to rats, mice, hamsters, guinea pigs or rabbits. Subjects will be recruited in the laboratories of the University of S. Paulo and State University of Campinas (Unicamp). Exposed subjects will be randomly allocated to two groups: treatment and placebo. Both groups will be followed up for two years. Subjects will be evaluated at baseline, after one year and after two years.
Treatment: 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 and the control group will receive once daily similar capsules containing placebo.
Procedures: blood sampling for blood cell counts, measurement of total IgE levels, specific immunoglobulin E (IgE) for rats, mice, hamsters, guinea pigs and rabbits; stool samples to test for parasites and for probiotic bacteria; skin prick test for animal allergens and common allergens, i.e. cockroaches, house dust mites, cats, dogs and mixed fungi; spirometry; and evaluation of bronchial responsiveness by bronchial challenge tests if the participant develop respiratory symptoms.
At the end of two years, changes in sensitization, bronchial responsiveness or symptoms in the treatment group compared to the placebo group will be considered the effect of probiotics.
Data analysis: group results will be compared by the chi-squared test regarding the prevalence of sensitization and other categorical variables. For continuous variables such as IgE levels, comparisons will be made by Student's t test. These analyses will be performed at the 1- and 2-year time points.
- Conditions
- Asthma Occupational
- Being tested
- Probiotic Formula, Placebo Oral Capsule
- Keywords
- probiotic
- Medical subject headings
- Asthma, Occupational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic FormulaDrug
Also called L. rhamnosus, L. paracasei, B. Lactis
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
Placebo Oral CapsuleOther
Also called Probiotic diluent
Capsule containing no probiotic
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Probiotic Formula |
| Placebo Oral Capsule | Placebo comparator | The control group will receive once daily similar capsules containing placebo. Receives: Other: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (1)
Assessment of symptoms
All subjects will respond to the respiratory symptoms questionnaire of the European Community Respiratory Health Survey (ECRHS), translated and validated by Ribeiro et al. (2007). In addition, both groups will respond to a questionnaire about symptoms of allergic rhinitis, asthma and allergic skin disease, previous exposure to laboratory animals, a personal and family history of allergic diseases, as well as gastrointestinal, urinary and infectious symptoms
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Asthma OccupationalStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Principal investigator, Elcio Vianna, University of Sao Paulo
- Investigators
- Elcio O Vianna, MD, PHD, Principal investigator, University of S. Paulo Medical School of Rib. Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021161
- Sponsor's protocol ID
- 548/2016
- Acronym
- prob&asthma
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21058157Ferraz 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.
PubMed 23778494Fiocchi 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.
PubMed 25628773Gandhi 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.
PubMed 25883597Gerrard 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.
PubMed 987744GLOBAL INITIATIVE FOR ASTHMA. Global strategy for asthma management and prevention 2014. <http://www.ginasthma.org/local/uploads/files/GINA_Report_2014_Jun11.pdf>.
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.
PubMed 8749632Johansson 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.
PubMed 15131563Kalliomaki 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.
PubMed 11150002Leynaert 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.
PubMed 14713912Petschow 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.
PubMed 16145341Freitas 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.
PubMed 27153990Prescott 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.
PubMed 17544096Simoneti 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.
PubMed 26490427Snydman DR. The safety of probiotics. Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S104-11; discussion S144-51. doi: 10.1086/523331.
PubMed 18181712
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Asthma Risk in Animal Laboratory Workers: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03021161
- Acronym / sponsor ID
- prob&asthma / 548/2016
- Conditions
- Asthma Occupational
- Keywords
- probiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION: The objective of the present project is to test the effect of probiotics on occupational allergic sensitization, respiratory symptoms and bronchial hyperresponsiveness in workers or students exposed to laboratory animals, i.e., small rodents.
Furthermore, our study aims to determine changes in immunological patterns with the use of probiotics in adulthood, which could prevent allergic sensitization and allergic diseases.
Probiotics have been used as treatment in various allergic diseases, especially as prevention of child atopic dermatitis by using them during pregnancy, or for neonates and infants.
STUDY DESIGN AND METHODS: This will be a randomized controlled trial involving laboratory animal workers and students exposed to rats, mice, hamsters, guinea pigs or rabbits. Subjects will be recruited in the laboratories of the University of S. Paulo and State University of Campinas (Unicamp). Exposed subjects will be randomly allocated to two groups: treatment and placebo. Both groups will be followed up for two years. Subjects will be evaluated at baseline, after one year and after two years.
Treatment: 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 and the control group will receive once daily similar capsules containing placebo.
Procedures: blood sampling for blood cell counts, measurement of total IgE levels, specific immunoglobulin E (IgE) for rats, mice, hamsters, guinea pigs and rabbits; stool samples to test for parasites and for probiotic bacteria; skin prick test for animal allergens and common allergens, i.e. cockroaches, house dust mites, cats, dogs and mixed fungi; spirometry; and evaluation of bronchial responsiveness by bronchial challenge tests if the participant develop respiratory symptoms.
At the end of two years, changes in sensitization, bronchial responsiveness or symptoms in the treatment group compared to the placebo group will be considered the effect of probiotics.
Data analysis: group results will be compared by the chi-squared test regarding the prevalence of sensitization and other categorical variables. For continuous variables such as IgE levels, comparisons will be made by Student's t test. These analyses will be performed at the 1- and 2-year time points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Probiotic FormulaThe 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). |
| Placebo Oral Capsule | Placebo comparator | Other: Placebo Oral CapsuleThe control group will receive once daily similar capsules containing placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic FormulaAlso: L. rhamnosus, L. paracasei, B. LactisThe intervention group will receive once daily capsules containing 109 CFU of Lactobacillus rhamnosus HN001, Lactobacillus paracasei Lpc-37 and Bifidobacterium animalis ssp. Lactis HN019 | Drug | intervention group |
| Placebo Oral CapsuleAlso: Probiotic diluentCapsule containing no probiotic | Other | Placebo Oral Capsule |
Primary outcome
detection the reduction of sensitization in workers exposed to laboratory animal
Time frame: two years
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.
1 secondary outcome
Assessment of symptoms
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Background: PubMed 21058157Curtin-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.
- Background: PubMed 23778494Ferraz 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.
- Background: PubMed 25628773Fiocchi 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.
- Background: PubMed 25883597Gandhi 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.
- Background: PubMed 987744Gerrard 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.
- BackgroundGLOBAL INITIATIVE FOR ASTHMA. Global strategy for asthma management and prevention 2014. <http://www.ginasthma.org/local/uploads/files/GINA_Report_2014_Jun11.pdf>.
- Background: PubMed 8749632Horwitch 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.
- Background: PubMed 15131563Johansson 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.
- Background: PubMed 11150002Kalliomaki 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.
- Background: PubMed 14713912Leynaert 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.
- Background: PubMed 16145341Petschow 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.
- Background: PubMed 27153990Freitas 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elcio O Vianna, MD, PHD principal investigator
University of S. Paulo Medical School of Rib. Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic Formula in people with Asthma Occupational, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elcio O Vianna, MD, PHD (55-16-36022706, evianna@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection the reduction of sensitization in workers exposed to laboratory animal (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021161, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.