Safety of VSL#3 in Adult Asthmatics

Asthma Clinical Trial

Official title: Safety of VSL#3 for Adult Asthmatics

Status Terminated

Clinical 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.

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

Clinical Trial Description

The monitored parameters that will be assessed at each clinic visit or phone call include:

1. the number of days with asthma related symptoms of cough, wheeze, dyspnea, awakening at night, and exercise limitation.

2. the number of asthma-related missed school/work days

3. the amount of use of asthma rescue medications

4. use of non-inhaled steroids

5. change in medications from baseline visit

6. diarrhea/liquid stools (> 2/day)

7. constipation

8. gas/bloating

9. fever/chills

10. 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:

1. change in lung function with spirometry.

2. women of childbearing potential will have repeat urine pregnancy testing at each clinic visit.

3. intestinal barrier function

4. intestinal flora

5. serum inflammatory cytokines and IgE ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT00852124
• Study type: Interventional
• Source: University of Maryland, Baltimore
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2007
• Completion date: January 2013