Safety of VSL#3 in Adult Asthmatics

This study has been terminated.
(Inadequate recruitment)
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Alessio Fasano, University of Maryland
ClinicalTrials.gov Identifier:
NCT00852124
First received: February 13, 2009
Last updated: June 22, 2015
Last verified: June 2015
Results First Received: December 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Biological: VSL#3
Biological: VSL#3 or placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between December 2010 and November 2012. Participants were recruited via flyers and newsletters.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Packets similar to VSL#3 taken 2 X daily but not containing active bacteria

VSL#3 or placebo : 1 packet 2 x daily of placebo

VSL#3

Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.

VSL#3 : VSL#3 2 times daily


Participant Flow:   Overall Study
    Placebo     VSL#3  
STARTED     3     0  
COMPLETED     3     0  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Zero participants analyzed for the primary outcome due to early termination of study

Reporting Groups
  Description
Placebo

Packets similar to VSL#3 taken 2 X daily but not containing active bacteria

VSL#3 or placebo : 1 packet 2 x daily of placebo

VSL#3

Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.

VSL#3 : VSL#3 2 times daily

Total Total of all reporting groups

Baseline Measures
    Placebo     VSL#3     Total  
Number of Participants  
[units: participants]
  3     0     3  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     3         3  
>=65 years     0         0  
Gender  
[units: participants]
     
Female     2         2  
Male     1         1  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0         0  
Asian     0         0  
Native Hawaiian or Other Pacific Islander     0         0  
Black or African American     0         0  
White     3         3  
More than one race     0         0  
Unknown or Not Reported     0         0  
Region of Enrollment  
[units: participants]
     
United States     3         3  



  Outcome Measures

1.  Primary:   To Establish the Safety of VSL#3 in Adults Asthmatics   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to small number of persons recruited before PI relocated.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alessio Fasano
Organization: UMARYLAND
phone: 617-726-1450
e-mail: afasano@partners.org


Publications:


Responsible Party: Alessio Fasano, University of Maryland
ClinicalTrials.gov Identifier: NCT00852124     History of Changes
Other Study ID Numbers: HP-00040151
1R21AT004089-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: February 13, 2009
Results First Received: December 2, 2014
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration