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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Dietary Supplement: Immunolin®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImmunoLin®<br>8-week treatment course | Dietary Supplement: Immunolin®<br>* Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, diarrhea