AsthmaPhase 1/2NCT00852124
Safety of VSL#3 in Adult Asthmatics
A Phase 1/2 study testing VSL#3 in people with Asthma, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jan 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults age 18-64 years old.
- Doctor diagnosis of mild persistent asthma. Persistent asthma is defined by NAEPP guidelines as asthma symptoms (cough/wheeze/dyspnea/exercise limitation)of greater than 2 times/week daytime or greater than 2 times/month at night over the previous month but less than continual and less than 5 nights/week.
- FEV1 greater than 60% predicted for age/gender/race/height based on normative data.
- No unscheduled asthma related health visit in the 1 month prior to enrollment
- School or work days missed less than or equal to 2 in the previous month for asthma.
- Albuterol use less than 8 doses (2 puffs or one neb) in past week.
Show all 9Show fewer
- Ability to speak and understand English.
- Telephone access.
- Women of childbearing potential must confirm that they will use birth control while in the study and have a negative urine pregnancy screen at baseline.
Who cannot join
- Pregnant women, prisoners.
- Chronic illness (other than asthma, allergic rhinitis and eczema) such as renal disease, diabetes, hypertension or terminal disease or abnormal vital signs: T> 100.3F, HR>130 bpm, SBP>155 mmHg, or DBP>100 mmHg, RR>25 bpm, or pox<93% room air.
- Unable to perform spirometry, necessary for lung function assessment.
- Received probiotic in past 6 months.
- Subject or household member has immunosuppression such as HIV, history of organ transplantation, present cancer or chemotherapy, primary immune disease, or is taking an immune modulating drug.
- Severe persistent asthmatics who have continual daily or frequent (greater than 5 nights/week) asthma symptoms and/or FEV1 less than 60% predicted .
Show all 11Show fewer
- Diarrhea or constipation (symptoms more than once in the past week)
- Unable to feed orally or to consume cornstarch
- Lung disease other than asthma (e.g. COPD, cystic fibrosis, lung cancer, bronchiectasis, interstitial lung disease).
- Subjects at increased risk of developing infective endocarditis such as those with a history of cardiac surgery, IV drug abuse, recent invasive medical procedures or dental work (recent = last month).
- Allergy to Vancomycin or Cefepime. The parameters of intestinal barrier function, intestinal flora, serum inflammatory cytokines, IgE, will have no exclusion ranges as these will be collected over time on product as a way of describing the population characteristics of study participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Safety of VSL#3 for Adult Asthmatics
We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol.
Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily for 3 months. Data will be collected, including age, race, height, and weight, present medications, past medical history with emphasis on signs/symptoms of asthma.
On visits to the clinic we will evaluate
- Changes in lung function
- Intestinal permeability
- Intestinal bacteria
- Levels of inflammation in the blood
- Women will have repeat urine pregnancy testing at each clinic visit
Read the detailed description
The monitored parameters that will be assessed at each clinic visit or phone call include:
- the number of days with asthma related symptoms of cough, wheeze, dyspnea, awakening at night, and exercise limitation.
- the number of asthma-related missed school/work days
- the amount of use of asthma rescue medications
- use of non-inhaled steroids
- change in medications from baseline visit
- diarrhea/liquid stools (> 2/day)
- constipation
- gas/bloating
- fever/chills
- scheduled or unscheduled visits for health care
To monitor for increased risk of safety concerns, we will also inquire on follow up visits and phone calls about the following:
- household member with immunosuppression such as HIV or chemotherapy.
On visits to the clinic we will evaluate lung function by spirometry:
- change in lung function with spirometry.
- women of childbearing potential will have repeat urine pregnancy testing at each clinic visit.
- intestinal barrier function
- intestinal flora
- serum inflammatory cytokines and IgE
- Conditions
- Asthma
- Being tested
- VSL#3, VSL#3 or placebo
- Keywords
- Asthma, Probiotic, VSL#3
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Biological
VSL#3 2 times daily
VSL#3 or placeboBiological
1 packet 2 x daily of placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Packets similar to VSL#3 will be taken 2 X daily but not containing active bacteria Receives: Biological: VSL#3 or placebo |
| VSL#3 | Active comparator | Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial) will be taken 2 x daily in food or a cool beverage. Receives: Biological: VSL#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of VSL#3 in Adults Asthmatics
Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2007
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Mucosal Biology Research Center, University of Maryland, Baltimore
- Investigators
- Alessio Fasano, M. D., Principal investigator, MBRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852124
- Sponsor's protocol ID
- HP-00040151
- Other IDs
- 1R21AT004089-01A1
- Status last verified
- Nov 2022
- First submitted
- 13 Feb 2009
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bienenstock J, Wiley RE, Neigh GS, Waserman S, Keith P. Probiotics in the management and prevention of atopy. Clin Rev Allergy Immunol. 2002 Jun;22(3):275-85. doi: 10.1007/s12016-002-0012-z. No abstract available.
PubMed 12043385Hijazi N, Abalkhail B, Seaton A. Diet and childhood asthma in a society in transition: a study in urban and rural Saudi Arabia. Thorax. 2000 Sep;55(9):775-9. doi: 10.1136/thorax.55.9.775.
PubMed 10950897Kalliomaki M, Isolauri E. Role of intestinal flora in the development of allergy. Curr Opin Allergy Clin Immunol. 2003 Feb;3(1):15-20. doi: 10.1097/00130832-200302000-00003.
PubMed 12582309Bjorksten B, Naaber P, Sepp E, Mikelsaar M. The intestinal microflora in allergic Estonian and Swedish 2-year-old children. Clin Exp Allergy. 1999 Mar;29(3):342-6. doi: 10.1046/j.1365-2222.1999.00560.x.
PubMed 10202341Hijazi Z, Molla AM, Al-Habashi H, Muawad WM, Molla AM, Sharma PN. Intestinal permeability is increased in bronchial asthma. Arch Dis Child. 2004 Mar;89(3):227-9. doi: 10.1136/adc.2003.027680.
PubMed 14977697Isolauri E, Salminen S; Nutrition, Allergy, Mucosal Immunology, and Intestinal Microbiota (NAMI) Research Group Report. Probiotics: use in allergic disorders: a Nutrition, Allergy, Mucosal Immunology, and Intestinal Microbiota (NAMI) Research Group Report. J Clin Gastroenterol. 2008 Jul;42 Suppl 2:S91-6. doi: 10.1097/MCG.0b013e3181639a98.
PubMed 18542035Kalliomaki M, Salminen S, Poussa T, Isolauri E. Probiotics during the first 7 years of life: a cumulative risk reduction of eczema in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 Apr;119(4):1019-21. doi: 10.1016/j.jaci.2006.12.608. Epub 2007 Feb 7. No abstract available.
PubMed 17289135Laitinen K, Kalliomaki M, Poussa T, Lagstrom H, Isolauri E. Evaluation of diet and growth in children with and without atopic eczema: follow-up study from birth to 4 years. Br J Nutr. 2005 Oct;94(4):565-74. doi: 10.1079/bjn20051503.
PubMed 16197582Von Ehrenstein OS, Von Mutius E, Illi S, Baumann L, Bohm O, von Kries R. Reduced risk of hay fever and asthma among children of farmers. Clin Exp Allergy. 2000 Feb;30(2):187-93. doi: 10.1046/j.1365-2222.2000.00801.x.
PubMed 10651770Noverr MC, Noggle RM, Toews GB, Huffnagle GB. Role of antibiotics and fungal microbiota in driving pulmonary allergic responses. Infect Immun. 2004 Sep;72(9):4996-5003. doi: 10.1128/IAI.72.9.4996-5003.2004.
PubMed 15321991Kalliomaki 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.
PubMed 11297958Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8. doi: 10.1046/j.1365-2222.2000.00948.x.
PubMed 11122221Isolauri E, Sutas Y, Kankaanpaa P, Arvilommi H, Salminen S. Probiotics: effects on immunity. Am J Clin Nutr. 2001 Feb;73(2 Suppl):444S-450S. doi: 10.1093/ajcn/73.2.444s.
PubMed 11157355Weizman Z, Asli G, Alsheikh A. Effect of a probiotic infant formula on infections in child care centers: comparison of two probiotic agents. Pediatrics. 2005 Jan;115(1):5-9. doi: 10.1542/peds.2004-1815.
PubMed 15629974Land MH, Rouster-Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus sepsis associated with probiotic therapy. Pediatrics. 2005 Jan;115(1):178-81. doi: 10.1542/peds.2004-2137.
PubMed 15629999
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of VSL#3 for Adult Asthmatics
- ClinicalTrials.gov ID
- NCT00852124
- Acronym / sponsor ID
- HP-00040151
- Conditions
- Asthma
- Keywords
- Asthma, Probiotic, VSL#3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Posted 10 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol.
Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily for 3 months. Data will be collected, including age, race, height, and weight, present medications, past medical history with emphasis on signs/symptoms of asthma.
On visits to the clinic we will evaluate
- Changes in lung function
- Intestinal permeability
- Intestinal bacteria
- Levels of inflammation in the blood
- Women will have repeat urine pregnancy testing at each clinic visit
Detailed description
The monitored parameters that will be assessed at each clinic visit or phone call include:
- the number of days with asthma related symptoms of cough, wheeze, dyspnea, awakening at night, and exercise limitation.
- the number of asthma-related missed school/work days
- the amount of use of asthma rescue medications
- use of non-inhaled steroids
- change in medications from baseline visit
- diarrhea/liquid stools (> 2/day)
- constipation
- gas/bloating
- fever/chills
- scheduled or unscheduled visits for health care
To monitor for increased risk of safety concerns, we will also inquire on follow up visits and phone calls about the following:
- household member with immunosuppression such as HIV or chemotherapy.
On visits to the clinic we will evaluate lung function by spirometry:
- change in lung function with spirometry.
- women of childbearing potential will have repeat urine pregnancy testing at each clinic visit.
- intestinal barrier function
- intestinal flora
- serum inflammatory cytokines and IgE
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: VSL#3 or placeboPackets similar to VSL#3 will be taken 2 X daily but not containing active bacteria |
| VSL#3 | Active comparator | Biological: VSL#3Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial) will be taken 2 x daily in food or a cool beverage. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults age 18-64 years old.
- Doctor diagnosis of mild persistent asthma. Persistent asthma is defined by NAEPP guidelines as asthma symptoms (cough/wheeze/dyspnea/exercise limitation)of greater than 2 times/week daytime or greater than 2 times/month at night over the previous month but less than continual and less than 5 nights/week.
- FEV1 greater than 60% predicted for age/gender/race/height based on normative data.
- No unscheduled asthma related health visit in the 1 month prior to enrollment
- School or work days missed less than or equal to 2 in the previous month for asthma.
Key exclusion criteria (11 listed)
- Pregnant women, prisoners.
- Chronic illness (other than asthma, allergic rhinitis and eczema) such as renal disease, diabetes, hypertension or terminal disease or abnormal vital signs: T> 100.3F, HR>130 bpm, SBP>155 mmHg, or DBP>100 mmHg, RR>25 bpm, or pox<93% room air.
- Unable to perform spirometry, necessary for lung function assessment.
- Received probiotic in past 6 months.
- Subject or household member has immunosuppression such as HIV, history of organ transplantation, present cancer or chemotherapy, primary immune disease, or is taking an immune modulating drug.
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 |
|---|---|---|
| VSL#3VSL#3 2 times daily | Biological | VSL#3 |
| VSL#3 or placebo1 packet 2 x daily of placebo | Biological | Placebo |
Primary outcome
Safety of VSL#3 in Adults Asthmatics
Time frame: 3 months
Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12043385Bienenstock J, Wiley RE, Neigh GS, Waserman S, Keith P. Probiotics in the management and prevention of atopy. Clin Rev Allergy Immunol. 2002 Jun;22(3):275-85. doi: 10.1007/s12016-002-0012-z. No abstract available.
- Background: PubMed 10950897Hijazi N, Abalkhail B, Seaton A. Diet and childhood asthma in a society in transition: a study in urban and rural Saudi Arabia. Thorax. 2000 Sep;55(9):775-9. doi: 10.1136/thorax.55.9.775.
- Background: PubMed 12582309Kalliomaki M, Isolauri E. Role of intestinal flora in the development of allergy. Curr Opin Allergy Clin Immunol. 2003 Feb;3(1):15-20. doi: 10.1097/00130832-200302000-00003.
- Background: PubMed 10202341Bjorksten B, Naaber P, Sepp E, Mikelsaar M. The intestinal microflora in allergic Estonian and Swedish 2-year-old children. Clin Exp Allergy. 1999 Mar;29(3):342-6. doi: 10.1046/j.1365-2222.1999.00560.x.
- Background: PubMed 14977697Hijazi Z, Molla AM, Al-Habashi H, Muawad WM, Molla AM, Sharma PN. Intestinal permeability is increased in bronchial asthma. Arch Dis Child. 2004 Mar;89(3):227-9. doi: 10.1136/adc.2003.027680.
- Background: PubMed 18542035Isolauri E, Salminen S; Nutrition, Allergy, Mucosal Immunology, and Intestinal Microbiota (NAMI) Research Group Report. Probiotics: use in allergic disorders: a Nutrition, Allergy, Mucosal Immunology, and Intestinal Microbiota (NAMI) Research Group Report. J Clin Gastroenterol. 2008 Jul;42 Suppl 2:S91-6. doi: 10.1097/MCG.0b013e3181639a98.
- Background: PubMed 17289135Kalliomaki M, Salminen S, Poussa T, Isolauri E. Probiotics during the first 7 years of life: a cumulative risk reduction of eczema in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 Apr;119(4):1019-21. doi: 10.1016/j.jaci.2006.12.608. Epub 2007 Feb 7. No abstract available.
- Background: PubMed 16197582Laitinen K, Kalliomaki M, Poussa T, Lagstrom H, Isolauri E. Evaluation of diet and growth in children with and without atopic eczema: follow-up study from birth to 4 years. Br J Nutr. 2005 Oct;94(4):565-74. doi: 10.1079/bjn20051503.
- Background: PubMed 10651770Von Ehrenstein OS, Von Mutius E, Illi S, Baumann L, Bohm O, von Kries R. Reduced risk of hay fever and asthma among children of farmers. Clin Exp Allergy. 2000 Feb;30(2):187-93. doi: 10.1046/j.1365-2222.2000.00801.x.
- Background: PubMed 15321991Noverr MC, Noggle RM, Toews GB, Huffnagle GB. Role of antibiotics and fungal microbiota in driving pulmonary allergic responses. Infect Immun. 2004 Sep;72(9):4996-5003. doi: 10.1128/IAI.72.9.4996-5003.2004.
- Background: PubMed 11297958Kalliomaki 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.
- Background: PubMed 11122221Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8. doi: 10.1046/j.1365-2222.2000.00948.x.
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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.
Alessio Fasano, M. D. principal investigator
MBRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VSL#3 in people with Asthma, run by University of Maryland, Baltimore 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Apr 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety of VSL#3 in Adults Asthmatics (time frame: 3 months). 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 NCT00852124, which also lists 17 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 20 Apr 2023.