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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
March 10, 2011
March 14, 2011
September 15, 2013
March 24, 2017
June 15, 2017
March 2011
August 2012   (Final data collection date for primary outcome measure)
Number of Bowel Movements Per Day [ Time Frame: 8 weeks (56 days) ]
self-reported bowel movement in diary
frequency of GI-related symptoms after an 8-week treatment course [ Time Frame: 8 weeks (56 days) ]
Complete list of historical versions of study NCT01313910 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
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.
Not Provided
Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV
Dietary Supplement: Immunolin®
Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks
Experimental: ImmunoLin®
8-week treatment course
Intervention: Dietary Supplement: Immunolin®
Asmuth DM, Ma ZM, Albanese A, Sandler NG, Devaraj S, Knight TH, Flynn NM, Yotter T, Garcia JC, Tsuchida E, Wu TT, Douek DC, Miller CJ. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy. AIDS. 2013 Sep 10;27(14):2207-17. doi: 10.1097/QAD.0b013e328362e54c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • GI complaints consisting of at least 2 loose or watery stools per day or marked abdominal bloating that adversely effects activities of daily living (ADLs) or common social functioning for greater than 6 months, even though the symptomatology may wax and wane over that time period.
  • Subjects should have had routine testing to exclude enteric pathogens.
  • Subjects should have made an effort to identify food intolerance, especially lactose intolerance.
  • Symptoms should be believed to be independent of ART or other medications known to have the potential to cause similar GI complaints; either because the symptoms predate initiation of the medications or shifts between different options for ART has had no appreciable effect on symptoms.
  • Over the previous 6 months, alcohol use should be characterized as occasional with less than 1.5 ounces per day being the maximum estimated use (<2 beers or glasses of wine or 1 drink of hard liquor).
  • Subjects will be greater than 18 years of age.
  • Plasma HIV load should be suppressed to less than 400 cp/mL for at least four months, but there is no restriction on peripheral CD4+ T-cell count. Blips of <1000 cp/mL are allowed, provided that these are not associated with medication interruptions and that the pVL is undetectable before and after the observed blip.
  • Subjects are willing to maintain a food and GI-symptom diary while receiving the ImmunoLin® supplement.
  • Subjects should be willing to attempt to maintain a stable regimen of ART for the duration of the study unless indicated for patient safety.
  • Subjects should be free of antibiotic use for at least 3-weeks prior to study entry except for chronic antibiotics used for prophylaxis according to SOC in HIV management. Usage of antibiotics during the course of the study will be assessed on a case by case basis by the study team.
  • Subjects must be free of conditions which require chronic therapy that are known to alter the gut flora. Steroid use must be limited to intermittent topical preparations only which includes inhaled or dermatologic routes of application.

Exclusion Criteria:

  • known unrelated causes for GI abnormalities.
  • abnormal coagulation parameters (PT>1.2 ULN)
  • thrombocytopenia (platelet count <50,000 within 6 weeks)
  • contra-indications to upper endoscopy or conscious sedation
  • anemia (> grade 1 [appendix D])
  • aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
  • positive pregnancy test
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01313910
225193
201118675 ( Other Identifier: UC Davis )
No
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Proliant Health & Biologicals
Principal Investigator: David M. Asmuth, MD University of California, Davis Int Med: ID
University of California, Davis
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP