CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
This study is ongoing, but not recruiting participants.
Proliant Health & Biologicals
Information provided by (Responsible Party):
David Asmuth, MD, University of California, Davis
First received: March 10, 2011
Last updated: January 18, 2013
Last verified: January 2013
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.
Dietary Supplement: Immunolin®
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
Primary Outcome Measures:
- frequency of GI-related symptoms after an 8-week treatment course [ Time Frame: 8 weeks (56 days) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- frequency of pro-inflammatory bacterial orders [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
stool sample, duodenal aspirate, and duodenal biopsy tissue
- measures of gut permeability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
by the five-hour disaccharide absorption test and serum levels of bacteria antigens
- inflammation [ Time Frame: days 20, 40 & 56 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
8-week treatment course
Dietary Supplement: Immunolin®
Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313910
|UCD CTSC Clinical Research Center (CCRC)
|Mather, California, United States, 95655 |
University of California, Davis
Proliant Health & Biologicals
||David M. Asmuth, MD
||University of California, Davis Int Med: ID
No publications provided by University of California, Davis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
||David Asmuth, MD, Professor/ Principal Investigator, University of California, Davis
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 10, 2011
||January 18, 2013
||United States: Institutional Review Board
Keywords provided by University of California, Davis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 20, 2014
Digestive System Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases