CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements

• ClinicalTrials.gov Identifier: NCT01313910
• Recruitment Status: Completed
• First Posted: March 14, 2011
• Results First Posted: March 3, 2017
• Last Update Posted: June 15, 2017
• Sponsor: University of California, Davis
• Collaborator: Proliant Health & Biologicals
• Information provided by (Responsible Party): University of California, Davis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV	Dietary Supplement: Immunolin®	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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
• Study Start Date: March 2011
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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 of Results:

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.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT01313910
• Other Study ID Numbers: 225193; 201118675 ( Other Identifier: UC Davis )
• First Posted: March 14, 2011
• Results First Posted: March 3, 2017
• Last Update Posted: June 15, 2017
• Last Verified: May 2017

Keywords provided by University of California, Davis:

HIV; diarrhea

Additional relevant MeSH terms:

HIV Enteropathy; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases