CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01313910 |
Recruitment Status :
Completed
First Posted : March 14, 2011
Results First Posted : March 3, 2017
Last Update Posted : June 15, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Dietary Supplement: Immunolin® | Early Phase 1 |
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 |
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 |
- Number of Bowel Movements Per Day [ Time Frame: 8 weeks (56 days) ]self-reported bowel movement in diary
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313910
United States, California | |
UCD CTSC Clinical Research Center (CCRC) | |
Mather, California, United States, 95655 |
Principal Investigator: | David M. Asmuth, MD | University of California, Davis Int Med: ID |
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 Key Record Dates |
Results First Posted: | March 3, 2017 |
Last Update Posted: | June 15, 2017 |
Last Verified: | May 2017 |
HIV diarrhea |
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 |