Safety of VSL#3 in 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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Safety of VSL#3 for Adult Asthmatics|
- To Establish the Safety of VSL#3 in Adults Asthmatics [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Change in FEV
|Study Start Date:||February 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Packets similar to VSL#3 will be taken 2 X daily but not containing active bacteria
Biological: VSL#3 or placebo
1 packet 2 x daily of placebo
Active Comparator: VSL#3
Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial) will be taken 2 x daily in food or a cool beverage.
VSL#3 2 times daily
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)
- 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:
1. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852124
|United States, Maryland|
|University of Maryland Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Alessio Fasano, M. D.||MBRC|