Trial Outcomes & Findings for CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements (NCT NCT01313910)
NCT ID: NCT01313910
Last Updated: 2017-06-15
Results Overview
self-reported bowel movement in diary
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
8 weeks (56 days)
Results posted on
2017-06-15
Participant Flow
Patients with diagnosis of HIV enteropathy are eligible for enrollment.
Participant milestones
| Measure |
ImmunoLin®
2.5 grams twice daily for eight weeks
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
Baseline characteristics by cohort
| Measure |
ImmunoLin®
n=8 Participants
8-week treatment course
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 4.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeks (56 days)self-reported bowel movement in diary
Outcome measures
| Measure |
ImmunoLin®
n=8 Participants
8-week treatment course
|
|---|---|
|
Number of Bowel Movements Per Day
baseline stool frequency
|
5.8 bowel movements/day
Interval 5.0 to 8.4
|
|
Number of Bowel Movements Per Day
week-8 stool frequency
|
2 bowel movements/day
Interval 2.0 to 3.8
|
SECONDARY outcome
Timeframe: 8 weeks16S rDNA sequencing for Bacteroidetes/Firmicutes ratio
Outcome measures
| Measure |
ImmunoLin®
n=8 Participants
8-week treatment course
|
|---|---|
|
Frequency of Pro-inflammatory Bacterial Orders
baseline Bacteroidetes/Firmicutes ratio
|
0.27 ratio of Bacteroidetes/Firmicutes %
Interval 0.2 to 0.54
|
|
Frequency of Pro-inflammatory Bacterial Orders
week-8 Bacteroidetes/Firmicutes ratio
|
0.55 ratio of Bacteroidetes/Firmicutes %
Interval 0.37 to 0.92
|
SECONDARY outcome
Timeframe: 8 weeksfive-hour disaccharide absorption test
Outcome measures
| Measure |
ImmunoLin®
n=8 Participants
8-week treatment course
|
|---|---|
|
Measures of Gut Permeability
baseline permiability ratio
|
.024 percentage absorption
Interval 0.0 to 0.048
|
|
Measures of Gut Permeability
week-8 permeability ratio
|
0.032 percentage absorption
Interval 0.0 to 0.047
|
SECONDARY outcome
Timeframe: 8 weeksCD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)
Outcome measures
| Measure |
ImmunoLin®
n=8 Participants
8-week treatment course
|
|---|---|
|
Systemic Immune Activation
baseline CD8+ activation
|
20.1 % CD8/HLA-DR/CD38+
Interval 17.8 to 27.9
|
|
Systemic Immune Activation
week-8 CD8+ activation
|
20.3 % CD8/HLA-DR/CD38+
Interval 17.8 to 29.2
|
SECONDARY outcome
Timeframe: 8 weekschanges in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry
Outcome measures
| Measure |
ImmunoLin®
n=8 Participants
8-week treatment course
|
|---|---|
|
Duodenal Immune Reconstitution
baseline duodenal CD3+/CD4+ cells
|
213 CD3+/CD4+ per mm^2 lamina propria
Interval 66.0 to 266.0
|
|
Duodenal Immune Reconstitution
8 week duodenal CD3+/CD4+ cells
|
322 CD3+/CD4+ per mm^2 lamina propria
Interval 228.0 to 433.0
|
Adverse Events
ImmunoLin®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place