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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Dietary supplement: Immunolin®

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Mather, California, United States, 95655
      • UCD CTSC Clinical Research Center (CCRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ImmunoLin®; 8-week treatment course	Dietary supplement: Immunolin®; Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Bowel Movements Per Day	self-reported bowel movement in diary	8 weeks (56 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Proliant Health & Biologicals
• Investigators: Principal Investigator: David M. Asmuth, MD, University of California, Davis Int Med: ID

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: HIV; diarrhea
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Gastrointestinal Diseases; Intestinal Diseases; HIV Infections; HIV Enteropathy
• Other Study ID Numbers: 225193; 201118675 (Other Identifier: UC Davis)