Safety of VSL#3 in Adult Asthmatics

March 23, 2023 updated by: Mucosal Biology Research Center, University of Maryland, Baltimore

Safety of VSL#3 for Adult Asthmatics

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of VSL#3 in Adults Asthmatics
Time Frame: 3 months
Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Alessio Fasano, M. D., MBRC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00040151
  • 1R21AT004089-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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