This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Proliant Health & Biologicals
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01313910
First received: March 10, 2011
Last updated: May 24, 2017
Last verified: May 2017
Results First Received: September 15, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: HIV
Intervention: Dietary Supplement: Immunolin®

  Participant Flow
  Hide Participant Flow

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
  Hide 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.
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
  Hide 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
pilot open label study with eight subjects.


  More Information
  Hide More Information

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 )
Study First Received: March 10, 2011
Results First Received: September 15, 2013
Last Updated: May 24, 2017