HIVEarly Phase 1NCT01313910
CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
A Early Phase 1 study testing Immunolin® in people with HIV, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Immunolin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Aug 2012
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCD CTSC Clinical Research Center (CCRC)
Mather, California, 95655
About this study
Official title: CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
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.
- Conditions
- HIV
- Being tested
- Immunolin®
- Keywords
- HIV, diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunolin®Dietary supplement
Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| ImmunoLin® | Experimental | 8-week treatment course Receives: Dietary Supplement: Immunolin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bowel Movements Per Day
self-reported bowel movement in diary
Measured: 8 weeks (56 days)
Secondary outcomes (4)
Frequency of Pro-inflammatory Bacterial Orders
16S rDNA sequencing for Bacteroidetes/Firmicutes ratio
Measured: 8 weeks
Measures of Gut Permeability
five-hour disaccharide absorption test
Measured: 8 weeks
Systemic Immune Activation
CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)
Measured: 8 weeks
Duodenal Immune Reconstitution
changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Proliant Health & Biologicals
- Responsible party
- Sponsor
- Investigators
- David M. Asmuth, MD, Principal investigator, University of California, Davis Int Med: ID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313910
- Sponsor's protocol ID
- 225193
- Other IDs
- 201118675
- Status last verified
- May 2017
- First submitted
- 10 Mar 2011
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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 with HIV enteropathy. AIDS. 2013 Sep 10;27(14):2207-17. doi: 10.1097/QAD.0b013e328362e54c.
PubMed 23660579
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCRC: A Pilot Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
- ClinicalTrials.gov ID
- NCT01313910
- Acronym / sponsor ID
- 225193
- Conditions
- HIV
- Keywords
- HIV, diarrhea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Proliant Health & Biologicals
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Posted 3 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ImmunoLin® | Experimental | Dietary Supplement: Immunolin®8-week treatment course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (7 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunolin®Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks | Dietary supplement | ImmunoLin® |
Primary outcome
Number of Bowel Movements Per Day
Time frame: 8 weeks (56 days)
self-reported bowel movement in diary
4 secondary outcomes
Frequency of Pro-inflammatory Bacterial Orders
Time frame: 8 weeks
Measures of Gut Permeability
Time frame: 8 weeks
Systemic Immune Activation
Time frame: 8 weeks
Duodenal Immune Reconstitution
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23660579Asmuth 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 with HIV enteropathy. AIDS. 2013 Sep 10;27(14):2207-17. doi: 10.1097/QAD.0b013e328362e54c.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M. Asmuth, MD principal investigator
University of California, Davis Int Med: ID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Immunolin® in people with HIV, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Bowel Movements Per Day (time frame: 8 weeks (56 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.