Safety of VSL#3 in Adult Asthmatics

University of Maryland Baltimore (UMB)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Asthma

Treatments

Biological: VSL#3

Biological: VSL#3 or placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00852124

1R21AT004089-01A1 (U.S. NIH Grant/Contract)

HP-00040151

Details and patient eligibility

About

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

Full 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

Enrollment

3 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.
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.

Exclusion criteria

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 .
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.