Inadequate recruitment

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

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

Inclusion Criteria:

1. Adults age 18-64 years old.
2. 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.
3. FEV1 greater than 60% predicted for age/gender/race/height based on normative data.
4. No unscheduled asthma related health visit in the 1 month prior to enrollment
5. School or work days missed less than or equal to 2 in the previous month for asthma.
6. Albuterol use less than 8 doses (2 puffs or one neb) in past week.
7. Ability to speak and understand English.
8. Telephone access.
9. 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.

Exclusion Criteria:

1. Pregnant women, prisoners.
2. 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.
3. Unable to perform spirometry, necessary for lung function assessment.
4. Received probiotic in past 6 months.
5. 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.
6. Severe persistent asthmatics who have continual daily or frequent (greater than 5 nights/week) asthma symptoms and/or FEV1 less than 60% predicted .
7. Diarrhea or constipation (symptoms more than once in the past week)
8. Unable to feed orally or to consume cornstarch
9. Lung disease other than asthma (e.g. COPD, cystic fibrosis, lung cancer, bronchiectasis, interstitial lung disease).
10. 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).
11. 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.

Zero participants analyzed for the primary outcome due to early termination of study

6 months

No participants received Investigational Product. All thre particpants randomized to placebo arm. Recruitment was ended due to failure to recruit when PI relocated.

Early termination due to small number of persons recruited before PI relocated.