Safety of VSL#3 in Adult Asthmatics

This study is currently recruiting participants.
Verified June 2012 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Alessio Fasano, University of Maryland
ClinicalTrials.gov Identifier:
NCT00852124
First received: February 13, 2009
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Asthma
Biological: VSL#3
Biological: VSL#3 or placebo
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • To establish the safety of VSL#3 in adults asthmatics [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    to determine that VSL#3 is safe for persons with mild asthma


Estimated Enrollment: 30
Study Start Date: February 2007
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: VSL#3
VSL#3 2 times daily

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852124

Contacts
Contact: Elaine Leonard Puppa, RN,MEd,MSN,DHA 410-706-6810 epuppa@mbrc.umaryland.edu
Contact: Debby Santora, BS 410-706-3734 dsantora@peds.umaryland.edu

Locations
United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Elaine L Leonard Puppa, MEd,MSN, DHA    410-706-6810    epuppa@mbrc.umaryland.edu   
Contact: Debby Santora, B.S.    410-706-3734    dsantora@peds.umaryland.edu   
Principal Investigator: Alessio Fasano, MD         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Alessio Fasano, M. D. MBRC
  More Information

Publications:

Responsible Party: Alessio Fasano, Director Mucosal Biology Research Center, University of Maryland
ClinicalTrials.gov Identifier: NCT00852124     History of Changes
Other Study ID Numbers: HP-00040151, 1R21AT004089-01A1
Study First Received: February 13, 2009
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Asthma
Probiotic
VSL#3

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014