Safety of VSL#3 in Adult Asthmatics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00852124|
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : February 26, 2009
Results First Posted : June 10, 2015
Last Update Posted : April 13, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Biological: VSL#3 Biological: VSL#3 or placebo||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety of VSL#3 for Adult Asthmatics|
|Study Start Date :||February 2007|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
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
- To Establish the Safety of VSL#3 in Adults Asthmatics [ Time Frame: 3 months ]Change in FEV
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852124
|United States, Maryland|
|University of Maryland Baltimore|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Alessio Fasano, M. D.||MBRC|