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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of the study is to see if ImmunoLin® will reduce the frequency of bowel movements and gastrointestinal (GI) symptoms in HIV volunteers with persistent GI symptoms. The study will also examine the effect of ImmunoLin® on the bacteria in the gut and the immune system in gut tissue as well as in the blood.

Detailed Summary:
Sponsor: University of California, Davis

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

self-reported bowel movement in diary


Original Primary Outcome: frequency of GI-related symptoms after an 8-week treatment course [ Time Frame: 8 weeks (56 days) ]

Current Secondary Outcome:

  • Frequency of Pro-inflammatory Bacterial Orders [ Time Frame: 8 weeks ]
    16S rDNA sequencing for Bacteroidetes/Firmicutes ratio
  • Measures of Gut Permeability [ Time Frame: 8 weeks ]
    five-hour disaccharide absorption test
  • Systemic Immune Activation [ Time Frame: 8 weeks ]
    CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)
  • Duodenal Immune Reconstitution [ Time Frame: 8 weeks ]
    changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry


Original Secondary Outcome:

  • Frequency of Pro-inflammatory Bacterial Orders [ Time Frame: 8 weeks ]
    stool sample, duodenal aspirate, and duodenal biopsy tissue
  • Measures of Gut Permeability [ Time Frame: 8 weeks ]
    by the five-hour disaccharide absorption test and serum levels of bacteria antigens
  • inflammation [ Time Frame: days 20, 40 & 56 ]
    including CD8+ T-cells with an activated phenotype, stool calprotectin, and plasma/tissue pro-inflammatory cytokines and including LPS and D-dimer
  • CD3+/CD4+ and CD3+/CD8+ population frequencies [ Time Frame: 8 weeks ]
    duodenal tissue


Information By: University of California, Davis

Dates:
Date Received: March 10, 2011
Date Started: March 2011
Date Completion:
Last Updated: March 22, 2017
Last Verified: January 2017