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Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin (PSC)

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ClinicalTrials.gov Identifier: NCT01322386
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : March 4, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Kenneth L. Cox, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Primary Sclerosing Cholangitis
Biliary Atresia
Intervention: Drug: Vancomycin

  Participant Flow

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 by the Physician and research team at Lucille Packard and Stanford Hospital and Clinics from 2007 - 2010. The first participant was enrolled in November 2008, and the last participant was enrolled in October 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
11 PSC patients whose consent to participate was obtained did not participate in the Study.

Reporting Groups
  Description
Oral Vancomycin-Biliary Atresia Vancomycin: Oral 50mg/Kg per day for three months. Initially 10 infants with Biliary Atresia (BA) were planned for this study to determine if there was clinical response to oral vancomycin.
Oral Vancomycin/ Primary Sclerosing Cholangitis Vancomycin: Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months. Initially 10 children with Primary Sclerosing Cholangitis (PSC) were planned for this study to determine if there was clinical response to oral vancomycin.

Participant Flow:   Overall Study
    Oral Vancomycin-Biliary Atresia   Oral Vancomycin/ Primary Sclerosing Cholangitis
STARTED   10   11 
COMPLETED   10   9 
NOT COMPLETED   0   2 
Protocol Violation                0                1 
Physician Decision                0                1 



  Baseline Characteristics

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.
Based on the annual progress report sent dated 10/04/2010, all patients completed the study as planned except 2 children with PSC- 1 was non-compliant and the other had severe UC requiring Remicade which resulted in removal from Vancomycin study.

Reporting Groups
  Description
Oral Vancomycin-BIliary Atresia Enrolled- 10, Participated - 10,Completed - 10 (Based on Annual Progress Report in Oct 2010)
Oral Vancomycin - PSC Enrolled- 11, Participated - 10 ,Completed - 9 (Based on Annual Progress Report in Oct 2010)
Total Total of all reporting groups

Baseline Measures
   Oral Vancomycin-BIliary Atresia   Oral Vancomycin - PSC   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
Age, Customized 
[Units: Participants]
     
1-3 months   10   0   10 
2-4 years   0   3   3 
9-11 years   0   2   2 
12-16 years   0   6   6 
Gender 
[Units: Participants]
     
Female   6   5   11 
Male   4   6   10 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   5   10   15 
Hispanic   3   1   4 
African American   2   0   2 


  Outcome Measures

1.  Primary:   Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia   [ Time Frame: Within 3 months of therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kenneth L Cox, MD / Principal Investigator
Organization: Stanford University
phone: 650-723-5070
e-mail: KCox@stanfordchildrens.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kenneth L. Cox, Stanford University
ClinicalTrials.gov Identifier: NCT01322386     History of Changes
Other Study ID Numbers: 4751
First Submitted: February 10, 2011
First Posted: March 24, 2011
Results First Submitted: May 22, 2015
Results First Posted: March 4, 2016
Last Update Posted: May 18, 2016