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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
  Purpose
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.

Condition Intervention Phase
HIV Dietary Supplement: Immunolin® Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Number of Bowel Movements Per Day [ Time Frame: 8 weeks (56 days) ]
    self-reported bowel movement in diary


Secondary Outcome Measures:
  • 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


Enrollment: 8
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ImmunoLin®
8-week treatment course
Dietary Supplement: Immunolin®
Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313910

Locations
United States, California
UCD CTSC Clinical Research Center (CCRC)
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Proliant Health & Biologicals
Investigators
Principal Investigator: David M. Asmuth, MD University of California, Davis Int Med: ID
  More Information

Publications:
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

Keywords provided by University of California, Davis:
HIV
diarrhea

Additional relevant MeSH terms:
HIV Enteropathy
HIV Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2017