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) ]
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