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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313910
• Other study ID #: 225193 (201118675)
• Status: Completed
• Phase: Early Phase 1
• First received: March 10, 2011
• Last updated: March 22, 2017
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• HIV Enteropathy
• Intestinal Diseases

Intervention

Dietary Supplement:
• Immunolin®
Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks

Locations

Country	Name	City	State
United States	UCD CTSC Clinical Research Center (CCRC)	Mather	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Proliant Health & Biologicals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Bowel Movements Per Day	self-reported bowel movement in diary	8 weeks (56 days)
Secondary	Frequency of Pro-inflammatory Bacterial Orders	16S rDNA sequencing for Bacteroidetes/Firmicutes ratio	8 weeks
Secondary	Measures of Gut Permeability	five-hour disaccharide absorption test	8 weeks
Secondary	Systemic Immune Activation	CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)	8 weeks
Secondary	Duodenal Immune Reconstitution	changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry	8 weeks