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CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01313910
First Posted: March 14, 2011
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Proliant Health & Biologicals
Information provided by (Responsible Party):
University of California, Davis
Results First Submitted: September 15, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Intervention: Dietary Supplement: Immunolin®

  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
Patients with diagnosis of HIV enteropathy are eligible for enrollment.

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
ImmunoLin® 2.5 grams twice daily for eight weeks

Participant Flow:   Overall Study
    ImmunoLin®
STARTED   8 
COMPLETED   8 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
ImmunoLin® 8-week treatment course

Baseline Measures
   ImmunoLin® 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.5  (4.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      8 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Bowel Movements Per Day   [ Time Frame: 8 weeks (56 days) ]

2.  Secondary:   Frequency of Pro-inflammatory Bacterial Orders   [ Time Frame: 8 weeks ]

3.  Secondary:   Measures of Gut Permeability   [ Time Frame: 8 weeks ]

4.  Secondary:   Systemic Immune Activation   [ Time Frame: 8 weeks ]

5.  Secondary:   Duodenal Immune Reconstitution   [ Time Frame: 8 weeks ]


  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
pilot open label study with eight subjects.


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


Results Point of Contact:  
Name/Title: David Asmuth, MD
Organization: UCaliforniaDavis
phone: 9167348695
e-mail: david.asmuth@ucdmc.ucdavis.edu


Publications of Results:

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01313910     History of Changes
Other Study ID Numbers: 225193
201118675 ( Other Identifier: UC Davis )
First Submitted: March 10, 2011
First Posted: March 14, 2011
Results First Submitted: September 15, 2013
Results First Posted: March 24, 2017
Last Update Posted: June 15, 2017