SmokingNCT01269723
Effects of Sulforaphane (SFN) on Immune Response to Live Attenuated Influenza Virus in Smokers and Nonsmokers
A study testing Broccoli sprout homogenate and Alfalfa sprout homogenate in people with Smoking, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant chemical called sulforaphane (SFN) which boosts production of certain "defense" enzymes that increase the activity of antioxidants. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Broccoli sprout homogenate and Alfalfa sprout homogenate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Mar 2013
- Phase
- Interventional
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, age 18-40 yr who are either nonsmokers OR smokers (> 0.5 pack/day);
- Willing to avoid corticosteroids and nonsteroidal anti-inflammatory medications for 1 week prior to study entry and again for 1 week prior to all remaining visits;
- Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with vitamin supplements added for 2 days prior to Day (-1) of the protocol and throughout the subsequent study.
Who cannot join
- Symptomatic allergies requiring medications for at least a 2 week interval during the past year;
- Respiratory infection (cough, sore throat, sinusitis, fever etc) within prior 4 weeks;
- Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
- Pregnancy or nursing;
- Asthma (other than wheezing occurring only in childhood); immunodeficiency (HIV or other); or any chronic medical condition that, in the opinion of the investigator, would preclude subject participation;
- Current use of immunosuppressive drugs;
Show all 14Show fewer
- History of fainting or feeling severely dizzy with blood draws;
- History of hypersensitivity, especially anaphylactic reactions, to egg proteins, gentamicin, gelatin, or arginine or with adverse reactions to previous influenza vaccinations;
- History of Guillain Barre syndrome;
- Smokers who have abnormal lung function on pulmonary function testing at the time of screening (FVC and FEV1 < 80% of that predicted based on subject age, gender, height and race);
- Subjects who will be unable to avoid contact with immunocompromised individuals for 3 weeks after receiving LAIV vaccine;
- Receipt of any type of influenza vaccine since August 2009;
- Diagnosed influenza illness since August 2009;
- History of intolerance of or aversion to broccoli.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599-7310
About this study
Official title: Effects of Sulforaphane (SFN)on Innate Immune Responses to Live Attenuated Influenza Virus in Smokers and Nonsmokers
Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant chemical called sulforaphane (SFN) which boosts production of certain "defense" enzymes that increase the activity of antioxidants. In animals, the chemical protection from SFN helps prevent diseases associated with inflammation and cancer among others, and this is currently being studied in humans.
Young broccoli sprouts have a particularly high level of SFN compared to other foods. The purpose of this research study is to learn about short term responses to live attenuated influenza virus (LAIV, administered to you via Flumist® vaccine) between smoking and nonsmoking volunteers treated with broccoli sprout homogenates ("shake") or a placebo homogenate. This will be done by obtaining a series of "nasal lavages" or rinses of your nose with salt water, as well as 3 superficial biopsies of the inside lining of your nose both before and after you receive the vaccine. Using these samples, we will measure the amount of virus and the amount of inflammation in your nose and compare how smokers and nonsmokers respond to the vaccine when they are given a broccoli sprout homogenate (high in SFN) or a placebo alfalfa spout "shake" which is low in SFN during each of 4 study visits.
Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to receive 1 of 2 homogenates. Broccoli sprout homogenate will be the the active treatment arm while the placebo arm will be alfalfa sprout homogenate. Two to 4 weeks after screening, subjects will return for 5 sequential visits (Monday-Friday). Monday-Thursday they will receive the assigned homogenate. On Tuesday, they will receive the Flumist®vaccine. Subjects will also be seen at 1 and 3 weeks post vaccine. Nasal lavage (NL), blood samples and nasal biopsies will performed prior to and after study interventions.
Read the detailed description
Schedule of visits:
Prior to the screening visit, subjects will be asked to avoid cruciferous vegetables (list will be provided to them), corticosteroids and nonsteroidal anti-inflammatory medications for 1 week prior to the initial visit and again for 1 week prior to all remaining visits. They will to also be asked to avoid antioxidant vitamins as well as juices/drinks with added vitamin supplements for 2 days prior to enrollment through study completion.
Baseline screening: obtain informed consent, review medical history, concomitant medications, vital signs (VS's), urine collection for analysis of cotinine and SFN metabolites for all subjects and urine pregnancy test for females of child bearing potential (all female subjects unless they are s/p oophorectomy), physical exam by study MD, complete symptom scoring, collect nasal lavage, and nasal biopsy (both nares), buccal swab collection and venipuncture (up to 75 cc's) will be performed for human immunodeficiency virus (HIV) test, baseline SFN level, immune mediators and SFN-induced gene expression changes. Food diaries will be provided with instructions for subjects at this visit
After successful completion of the screening, the subject will be randomized to receive broccoli sprout homogenates or alfalfa sprout homogenates during the next 4 study visits. Subjects will return 2-4 weeks after screening for 5 daily sequential visits (Monday through Friday).
Monday (Day -1): VS's, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites for all subjects and Hcg for females of child bearing potential, nasal lavage, observed ingestion of initial dose and continue food diaries started 3 days prior.
Tuesday (Day 0): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, observed ingestion of 2nd dose, NL, administration of LAIV, continue food diaries.
Wednesday (Day 1): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, observed ingestion of 3rd dose, NL and continue food diaries.
Thursday (Day 2): VS's, symptom/adverse event evaluation, review of concomitant medications and observed ingestion of 4th dose. Two hours after ingestion, urine collection for analysis of cotinine and SFN metabolites, venipuncture (up to 10 cc's for SFN level), nasal biopsy (left nare) and NL will be performed. Continue food diaries.
Friday (Day 3): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, NL, continue food diaries.
Day 7 (+/- 1 day): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, nasal biopsy (right nare), NL, continue food diaries.
Day 21 (+/- 1 week): VS's, symptom/adverse event evaluation, review of concomitant medications urine collection for analysis of cotinine and SFN metabolites, NL, venipuncture (up to 45 cc's) for immune mediators as well as SFN-induced gene expression changes and anti-influenza antibody level, collect completed food diary
- Conditions
- Smoking
- Being tested
- Broccoli sprout homogenate, Alfalfa sprout homogenate
- Keywords
- Smoking, influenza, influenza vaccine
- Medical subject headings
- Smoking, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli sprout homogenateDietary supplement
Also called Broccoli sprout shake
Subjects will drink the broccoli shake homogenate
Alfalfa sprout homogenateDietary supplement
Also called Alfalfa sprout shake
Subjects will drink the alfalfa sprout homogenate.
| Study group | Role | What they receive |
|---|---|---|
| Broccoli sprout homogenate | Active comparator | The broccoli sprouts and water are chopped in a blender until a uniform mix is obtained. Salt or sugar may be added to the "shake". Receives: Dietary Supplement: Broccoli sprout homogenate |
| alfalfa sprout homogenate | Placebo comparator | Alfalfa sprouts and water are chopped in a blender until a uniform mix is obtained. Salt or sugar may be added to the "shake". Receives: Dietary Supplement: Alfalfa sprout homogenate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 6 (IL-6) in NL after LAIV inoculation (expressed as area under curve for ratio of IL-6 to baseline) in smokers
This will be performed by repetitive spraying of sterile normal saline irrigation solution (5 ml total) into the nostril, followed by voluntary expelling of fluid by the subject into a specimen collection cup. Both nostrils are lavaged in this way and the resulting nasal lavage fluid (NLF) from both sides is combined.
Measured: at days 1, 2 ,3, 7 and 21 post LAIV
Secondary outcomes (1)
change in nasal cells-cytokines, chemokines, natural killer cell activation; tolerance of homogenate; nasal biopsy Nrf2, cytokine, and phase II enzyme mRNA; serum antibodies; blood cell response to influenza antigen
Nasal lavage is as previously described. Blood collection will be via venipuncture and nasal epithelial cells will be collected during a nasal scrape.
Measured: For nasal lavage-at days 1, 2 ,3, 7 and 21 post LAIV; for biopsy samples taken on Days 2 and 7 post LAIV; for blood endpoints-Days 2 and 21 post LAIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Terry Noah, MD, University of North Carolina, Chapel Hill
- Investigators
- Terry Noah, MD, Principal investigator, University of North Carolina at Chapel Hill School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269723
- Sponsor's protocol ID
- 10-1806
- Other IDs
- R01HL095163-02
- Status last verified
- Jan 2014
- First submitted
- 14 Dec 2010
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller L, Meyer M, Bauer RN, Zhou H, Zhang H, Jones S, Robinette C, Noah TL, Jaspers I. Effect of Broccoli Sprouts and Live Attenuated Influenza Virus on Peripheral Blood Natural Killer Cells: A Randomized, Double-Blind Study. PLoS One. 2016 Jan 28;11(1):e0147742. doi: 10.1371/journal.pone.0147742. eCollection 2016.
PubMed 26820305Noah TL, Zhang H, Zhou H, Glista-Baker E, Muller L, Bauer RN, Meyer M, Murphy PC, Jones S, Letang B, Robinette C, Jaspers I. Effect of broccoli sprouts on nasal response to live attenuated influenza virus in smokers: a randomized, double-blind study. PLoS One. 2014 Jun 9;9(6):e98671. doi: 10.1371/journal.pone.0098671. eCollection 2014.
PubMed 24910991
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sulforaphane (SFN)on Innate Immune Responses to Live Attenuated Influenza Virus in Smokers and Nonsmokers
- ClinicalTrials.gov ID
- NCT01269723
- Acronym / sponsor ID
- 10-1806
- Conditions
- Smoking
- Keywords
- Smoking, influenza, influenza vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jan 2011 (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.
Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant chemical called sulforaphane (SFN) which boosts production of certain "defense" enzymes that increase the activity of antioxidants. In animals, the chemical protection from SFN helps prevent diseases associated with inflammation and cancer among others, and this is currently being studied in humans.
Young broccoli sprouts have a particularly high level of SFN compared to other foods. The purpose of this research study is to learn about short term responses to live attenuated influenza virus (LAIV, administered to you via Flumist® vaccine) between smoking and nonsmoking volunteers treated with broccoli sprout homogenates ("shake") or a placebo homogenate. This will be done by obtaining a series of "nasal lavages" or rinses of your nose with salt water, as well as 3 superficial biopsies of the inside lining of your nose both before and after you receive the vaccine. Using these samples, we will measure the amount of virus and the amount of inflammation in your nose and compare how smokers and nonsmokers respond to the vaccine when they are given a broccoli sprout homogenate (high in SFN) or a placebo alfalfa spout "shake" which is low in SFN during each of 4 study visits.
Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to receive 1 of 2 homogenates. Broccoli sprout homogenate will be the the active treatment arm while the placebo arm will be alfalfa sprout homogenate. Two to 4 weeks after screening, subjects will return for 5 sequential visits (Monday-Friday). Monday-Thursday they will receive the assigned homogenate. On Tuesday, they will receive the Flumist®vaccine. Subjects will also be seen at 1 and 3 weeks post vaccine. Nasal lavage (NL), blood samples and nasal biopsies will performed prior to and after study interventions.
Detailed description
Schedule of visits:
Prior to the screening visit, subjects will be asked to avoid cruciferous vegetables (list will be provided to them), corticosteroids and nonsteroidal anti-inflammatory medications for 1 week prior to the initial visit and again for 1 week prior to all remaining visits. They will to also be asked to avoid antioxidant vitamins as well as juices/drinks with added vitamin supplements for 2 days prior to enrollment through study completion.
Baseline screening: obtain informed consent, review medical history, concomitant medications, vital signs (VS's), urine collection for analysis of cotinine and SFN metabolites for all subjects and urine pregnancy test for females of child bearing potential (all female subjects unless they are s/p oophorectomy), physical exam by study MD, complete symptom scoring, collect nasal lavage, and nasal biopsy (both nares), buccal swab collection and venipuncture (up to 75 cc's) will be performed for human immunodeficiency virus (HIV) test, baseline SFN level, immune mediators and SFN-induced gene expression changes. Food diaries will be provided with instructions for subjects at this visit
After successful completion of the screening, the subject will be randomized to receive broccoli sprout homogenates or alfalfa sprout homogenates during the next 4 study visits. Subjects will return 2-4 weeks after screening for 5 daily sequential visits (Monday through Friday).
Monday (Day -1): VS's, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites for all subjects and Hcg for females of child bearing potential, nasal lavage, observed ingestion of initial dose and continue food diaries started 3 days prior.
Tuesday (Day 0): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, observed ingestion of 2nd dose, NL, administration of LAIV, continue food diaries.
Wednesday (Day 1): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, observed ingestion of 3rd dose, NL and continue food diaries.
Thursday (Day 2): VS's, symptom/adverse event evaluation, review of concomitant medications and observed ingestion of 4th dose. Two hours after ingestion, urine collection for analysis of cotinine and SFN metabolites, venipuncture (up to 10 cc's for SFN level), nasal biopsy (left nare) and NL will be performed. Continue food diaries.
Friday (Day 3): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, NL, continue food diaries.
Day 7 (+/- 1 day): VS's, symptom/adverse event evaluation, review of concomitant medications, urine collection for analysis of cotinine and SFN metabolites, nasal biopsy (right nare), NL, continue food diaries.
Day 21 (+/- 1 week): VS's, symptom/adverse event evaluation, review of concomitant medications urine collection for analysis of cotinine and SFN metabolites, NL, venipuncture (up to 45 cc's) for immune mediators as well as SFN-induced gene expression changes and anti-influenza antibody level, collect completed food diary
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broccoli sprout homogenate | Active comparator | Dietary Supplement: Broccoli sprout homogenateThe broccoli sprouts and water are chopped in a blender until a uniform mix is obtained. Salt or sugar may be added to the "shake". |
| alfalfa sprout homogenate | Placebo comparator | Dietary Supplement: Alfalfa sprout homogenateAlfalfa sprouts and water are chopped in a blender until a uniform mix is obtained. Salt or sugar may be added to the "shake". |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults, age 18-40 yr who are either nonsmokers OR smokers (> 0.5 pack/day);
- Willing to avoid corticosteroids and nonsteroidal anti-inflammatory medications for 1 week prior to study entry and again for 1 week prior to all remaining visits;
- Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with vitamin supplements added for 2 days prior to Day (-1) of the protocol and throughout the subsequent study.
Key exclusion criteria (14 listed)
- Symptomatic allergies requiring medications for at least a 2 week interval during the past year;
- Respiratory infection (cough, sore throat, sinusitis, fever etc) within prior 4 weeks;
- Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
- Pregnancy or nursing;
- Asthma (other than wheezing occurring only in childhood); immunodeficiency (HIV or other); or any chronic medical condition that, in the opinion of the investigator, would preclude subject participation;
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 |
|---|---|---|
| Broccoli sprout homogenateAlso: Broccoli sprout shakeSubjects will drink the broccoli shake homogenate | Dietary supplement | Broccoli sprout homogenate |
| Alfalfa sprout homogenateAlso: Alfalfa sprout shakeSubjects will drink the alfalfa sprout homogenate. | Dietary supplement | alfalfa sprout homogenate |
Primary outcome
Interleukin 6 (IL-6) in NL after LAIV inoculation (expressed as area under curve for ratio of IL-6 to baseline) in smokers
Time frame: at days 1, 2 ,3, 7 and 21 post LAIV
This will be performed by repetitive spraying of sterile normal saline irrigation solution (5 ml total) into the nostril, followed by voluntary expelling of fluid by the subject into a specimen collection cup. Both nostrils are lavaged in this way and the resulting nasal lavage fluid (NLF) from both sides is combined.
1 secondary outcome
change in nasal cells-cytokines, chemokines, natural killer cell activation; tolerance of homogenate; nasal biopsy Nrf2, cytokine, and phase II enzyme mRNA; serum antibodies; blood cell response to influenza antigen
Time frame: For nasal lavage-at days 1, 2 ,3, 7 and 21 post LAIV; for biopsy samples taken on Days 2 and 7 post LAIV; for blood endpoints-Days 2 and 21 post LAIV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Derived from this study: PubMed 26820305Muller L, Meyer M, Bauer RN, Zhou H, Zhang H, Jones S, Robinette C, Noah TL, Jaspers I. Effect of Broccoli Sprouts and Live Attenuated Influenza Virus on Peripheral Blood Natural Killer Cells: A Randomized, Double-Blind Study. PLoS One. 2016 Jan 28;11(1):e0147742. doi: 10.1371/journal.pone.0147742. eCollection 2016.
- Derived from this study: PubMed 24910991Noah TL, Zhang H, Zhou H, Glista-Baker E, Muller L, Bauer RN, Meyer M, Murphy PC, Jones S, Letang B, Robinette C, Jaspers I. Effect of broccoli sprouts on nasal response to live attenuated influenza virus in smokers: a randomized, double-blind study. PLoS One. 2014 Jun 9;9(6):e98671. doi: 10.1371/journal.pone.0098671. eCollection 2014.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Terry Noah, MD principal investigator
University of North Carolina at Chapel Hill School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli sprout homogenate and Alfalfa sprout homogenate in people with Smoking, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 29 Jan 2014. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 6 (IL-6) in NL after LAIV inoculation (expressed as area under curve for ratio of IL-6 to baseline) in smokers (time frame: at days 1, 2 ,3, 7 and 21 post LAIV). 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 NCT01269723, which also lists 2 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 29 Jan 2014.