Alcohol Use DisorderNCT06139224
Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection
A study testing 4 week prebiotic consumption in people with Alcohol Use Disorder and Human Immunodeficiency Virus, run by Rush University Medical Center at 1 site in United States.
Trial summary
Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Human Immunodeficiency Virus
- What is being tested?
- 4 week prebiotic consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 to 75 years men and women
- Infection with HIV-1, as documented by a licensed ELISA and confirmed by a Western blot or HIV-1 RNA
- On ART for at least 12 months. No history of zidovudine (AZT) or stavudine (D4T) use.
- No change in ART for at least 6 months.
- CD4+ T cell count of > 250 cells/µl, nadir CD4+ T cell count of > 250 cells/µl
- Plasma HIV-1 RNA level consistently below the limit of detection of commercial ultrasensitive assay (usually <20 copies/mL) for at least six months before study entry.
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- For those for "AUD group" AUDIT-C =/> 4 for men and = ≥3 for women.
- Documented BMI between 25-40
- Ability and willingness to provide informed consent
Who cannot join
- Receipt of a non-HIV vaccine within 30 days
- Opportunistic infection within 30 days
- Immunosuppressive medications (e.g., systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer chemotherapy) within 90 days
- History of clinically significant medical disease that could potentially impact the integrity of intestinal barrier function or microbiota including renal (creatinine >2 mg/dL), liver (documented cirrhosis based on histology or ALT/AST greater than 2 1/2 times normal), cardiac failure (NY classification III/IV), or uncontrolled diabetes (Hgb-A1c>8%).
- Fiber intake > 15 grams.
- Chronic HBV and un-treated HCV (documentation of cure can be enrolled)
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- Herbal/botanical supplements with potential microbiome or anti-inflammatory effects (e.g., inulin/chicory fiber, berberine, high-dose polyphenols). Participants will be eligible to participant if they discontinue use for at least 2 weeks before enrollment.
- Regular use of medications that affect intestinal permeability including NSAIDs (daily more than three days a week during the prior two weeks). Type and frequency and duration of NSAID (those taking less than 3 /per week) should be recorded. If participants need to take antibiotics or NSAIDS during the study, duration, name, and dosage will be recorded but they will not be excluded.
- Antibiotics (during or prior) four weeks to enrollment. Type and duration of antibiotic treatment within 90 days should be recorded.
- Current use of a restrictive or specialty diet like vegan, vegetarian, gluten-free, Paleo, or any specific carbohydrate diet because these diets can impact the microbiota community.
- Use of herbal, botanical, or nutraceutical supplements with potential effects on the gut microbiome or systemic inflammation. This includes:
- prebiotic fibers such as inulin, chicory root, fructooligosaccharides (FOS), or galactooligosaccharides (GOS) botanical or herbal compounds with microbiome-modulating or anti-inflammatory properties, such as berberine, curcumin, resveratrol, or high-dose polyphenol Probiotics or synbiotics Digestive enzymes or other nutraceuticals reported to alter gut microbial composition.
- Potential participants may enroll if they discontinue use for at least 2 weeks before enrollment. Type, dosage, frequency, route of administration (for example oral), and date last taken will be documented at time of enrollment verify that a sufficient washout period has occurred before enrollment.
- -Have undergone bowel preparation or colonic (e.g., for a colonoscopy or similar procedure) for example, within 4 weeks prior to enrollment.
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease). Celiac disease. GI cancers
- Gastrointestinal surgeries/resection (cholecystectomy is accepted but should be recorded)
- Currently taking or planning to start a GLP-1 receptor agonist or dual GLP-1/GIP receptor agonist for weight loss or weight management. This includes medications such as semaglutide (Ozempic, Wegovy, Rybelsus), liraglutide (Victoza, Saxenda), dulaglutide (Trulicity), exenatide (Byetta, Bydureon), lixisenatide (Adlyxin), and tirzepatide (Mounjaro, Zepbound). Participants who previously used these medications may be eligible if they discontinued use at least 4 weeks prior to enrollment. For eligible individuals, the medication name, dosage, frequency, route of administration (for example injection or oral), and date of last dose will be documented at enrollment. The study team will document the last dose to verify that a sufficient wash out period has occurred before enrollment and to account for any possible microbiome differences.
- Use of PPI is accepted but type, dose and duration should be recorded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ali Keshavarzian
Chicago, Illinois, 60612
Ali Keshavarzian, M.D., 312-563-4175, ali_keshavarzian@rush.edu
About this study
Official title: Gut Microbiota-Mediated Inflammatory Interactions Between Alcohol Use Disorders and HIV Infection
Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans.
40 HIV+ ART+ (20 AUD- and 20 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept intervention study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will complete three in-person clinic visits and four virtual check-in visits during this 8 week study. This study uses a crossover design. At baseline, participants will be randomized to receive either a prebiotic or a placebo for the first intervention period. After completing this period, participants will cross over to receive the alternate study product for the second intervention period, allowing each participant to serve as their own control. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. New participants will also be recruited. Blood, urine, and stool, will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois.
- Conditions
- Alcohol Use Disorder, Human Immunodeficiency Virus
- Being tested
- 4 week prebiotic consumption, 4 week placebo consumption
- Medical subject headings
- Alcoholism, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 week prebiotic consumptionDietary supplement
For this crossover design, participants will be randomly assigned to take a prebiotic or placebo for 4 weeks and then switch to the other products. Participants and research coordinators will be blinded. Participants will be instructed to consume the prebiotic daily during the first three days and then twice daily for the remaining weeks. Participants will be instructed to consume the powder in the morning on the first three days, then in the morning and afternoon for the following weeks. They will record their prebiotic consumption and gastrointestinal symptoms in a daily log and have weekly check-ins with the research coordinator.
4 week placebo consumptionOther
For this crossover design, participants will be randomly assigned to take a prebiotic or placebo for 4 weeks and then switch to the other products. Participants and research coordinators will be blinded. Participants will be instructed to consume the placebo (maltodextrin) daily during the first three days and then twice daily for the remaining weeks. Participants will be instructed to consume the powder in the morning on the first three days, then in the morning and afternoon for the following weeks. They will record their prebiotic consumption and gastrointestinal symptoms in a daily log and have weekly check-ins with the research coordinator.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected ART-suppressed individuals with AUD | Experimental | Only 20 HIV+ ART+,AUD + individuals will be invited to take part in a prebiotic sub study, which they will take a prebiotic for 4 weeks and placebo for 4 weeks. Receives: Dietary Supplement: 4 week prebiotic consumption; Other: 4 week placebo consumption |
| HIV-infected ART-suppressed individuals with no AUD | Experimental | Only 20 HIV+ ART+,AUD - individuals will be invited to take part in a prebiotic sub study, which they will take a prebiotic for 4 weeks and placebo for 4 weeks. Receives: Dietary Supplement: 4 week prebiotic consumption; Other: 4 week placebo consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugar test for intestinal permeability after prebiotic and placebo consumption in substudy
Measure the permeation of sugar probes following an oral test dose of sugars as this is standard for evaluating intestinal barrier integrity
Measured: 8 weeks
Secondary outcomes (2)
Change in stool and intestinal microbiota composition after prebiotic and placebo consumption
A combination of 16S rRNA gene amplicon sequencing and shotgun metagenome sequencing will be used to characterize microbial community structure in intestinal biopsies and stool.
Measured: 8 weeks
Change in plasma and stool SCFA level before and after prebiotic treatment
Mass spectrometry and NMR
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 posted18 Nov 2023
- Study start5 Mar 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Crossover Assignment: Participants will be randomly assigned to receive the placebo or prebiotic first for 4 week and then switch over for the remaining 4 weeks.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Keshavarzian, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139224
- Sponsor's protocol ID
- 22112903
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota-Mediated Inflammatory Interactions Between Alcohol Use Disorders and HIV Infection
- ClinicalTrials.gov ID
- NCT06139224
- Acronym / sponsor ID
- 22112903
- Conditions
- Alcohol Use Disorder, Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans.
40 HIV+ ART+ (20 AUD- and 20 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept intervention study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will complete three in-person clinic visits and four virtual check-in visits during this 8 week study. This study uses a crossover design. At baseline, participants will be randomized to receive either a prebiotic or a placebo for the first intervention period. After completing this period, participants will cross over to receive the alternate study product for the second intervention period, allowing each participant to serve as their own control. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. New participants will also be recruited. Blood, urine, and stool, will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment: Participants will be randomly assigned to receive the placebo or prebiotic first for 4 week and then switch over for the remaining 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| HIV-infected ART-suppressed individuals with AUD | Experimental | Dietary Supplement: 4 week prebiotic consumption, Other: 4 week placebo consumptionOnly 20 HIV+ ART+,AUD + individuals will be invited to take part in a prebiotic sub study, which they will take a prebiotic for 4 weeks and placebo for 4 weeks. |
| HIV-infected ART-suppressed individuals with no AUD | Experimental | Dietary Supplement: 4 week prebiotic consumption, Other: 4 week placebo consumptionOnly 20 HIV+ ART+,AUD - individuals will be invited to take part in a prebiotic sub study, which they will take a prebiotic for 4 weeks and placebo for 4 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21 to 75 years men and women
- Infection with HIV-1, as documented by a licensed ELISA and confirmed by a Western blot or HIV-1 RNA
- On ART for at least 12 months. No history of zidovudine (AZT) or stavudine (D4T) use.
- No change in ART for at least 6 months.
- CD4+ T cell count of > 250 cells/µl, nadir CD4+ T cell count of > 250 cells/µl
Key exclusion criteria (18 listed)
- Receipt of a non-HIV vaccine within 30 days
- Opportunistic infection within 30 days
- Immunosuppressive medications (e.g., systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer chemotherapy) within 90 days
- History of clinically significant medical disease that could potentially impact the integrity of intestinal barrier function or microbiota including renal (creatinine >2 mg/dL), liver (documented cirrhosis based on histology or ALT/AST greater than 2 1/2 times normal), cardiac failure (NY classification III/IV), or uncontrolled diabetes (Hgb-A1c>8%).
- Fiber intake > 15 grams.
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 |
|---|---|---|
| 4 week prebiotic consumptionFor this crossover design, participants will be randomly assigned to take a prebiotic or placebo for 4 weeks and then switch to the other products. Participants and research coordinators will be blinded. Participants will be instructed to consume the prebiotic daily during the first three days and then twice daily for the remaining weeks. Participants will be instructed to consume the powder in the morning on the first three days, then in the morning and afternoon for the following weeks. They will record their prebiotic consumption and gastrointestinal symptoms in a daily log and have weekly check-ins with the research coordinator. | Dietary supplement | HIV-infected ART-suppressed individuals with AUD, HIV-infected ART-suppressed individuals with no AUD |
| 4 week placebo consumptionFor this crossover design, participants will be randomly assigned to take a prebiotic or placebo for 4 weeks and then switch to the other products. Participants and research coordinators will be blinded. Participants will be instructed to consume the placebo (maltodextrin) daily during the first three days and then twice daily for the remaining weeks. Participants will be instructed to consume the powder in the morning on the first three days, then in the morning and afternoon for the following weeks. They will record their prebiotic consumption and gastrointestinal symptoms in a daily log and have weekly check-ins with the research coordinator. | Other | HIV-infected ART-suppressed individuals with AUD, HIV-infected ART-suppressed individuals with no AUD |
Primary outcome
Sugar test for intestinal permeability after prebiotic and placebo consumption in substudy
Time frame: 8 weeks
Measure the permeation of sugar probes following an oral test dose of sugars as this is standard for evaluating intestinal barrier integrity
2 secondary outcomes
Change in stool and intestinal microbiota composition after prebiotic and placebo consumption
Time frame: 8 weeks
Change in plasma and stool SCFA level before and after prebiotic treatment
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 week prebiotic consumption in people with Alcohol Use Disorder and Human Immunodeficiency Virus, run by Rush University Medical Center 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 9 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Villanueva, M.S. (312-942-8927, Michelle_Villanueva@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sugar test for intestinal permeability after prebiotic and placebo consumption in substudy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.