Early Phase 1
N=8
CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01313910 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Bowel Movements Per Day — 5.8; 2 bowel movements/day — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Immunolin® (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Bowel Movements Per Day |
5.8; 2 | 0.008 sig |
| SECONDARY Frequency of Pro-inflammatory Bacterial Orders |
0.27; 0.55 | 0.11 |
| SECONDARY Measures of Gut Permeability |
.024; 0.032 | >0.05 |
| SECONDARY Systemic Immune Activation |
20.1; 20.3 | — |
| SECONDARY Duodenal Immune Reconstitution |
213; 322 | 0.016 sig |
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.
Eligibility 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 ( 1.2 ULN)
- thrombocytopenia (platelet count 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
Data sourced from ClinicalTrials.gov (NCT01313910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.