Prebiotics for AUD and HIV/AIDS

Recruiting at 1 trial location

Overseen By Lena DiBenedetto, B.S

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must be taking: Antiretrovirals

Must not be taking: Anticoagulants, Immunosuppressives, NSAIDs, others

Disqualifiers: Substance abuse, Obesity, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how prebiotics, such as oligofructose-enriched inulin (known as Prebiotin), can aid individuals with both HIV and alcohol use disorder (AUD) by enhancing gut health and reducing inflammation. Researchers believe that the combination of these conditions can damage the gut, increasing inflammation. The study will test whether prebiotics can protect the gut and lower inflammation in people with HIV, regardless of AUD status. It suits individuals living with HIV who are on antiretroviral therapy, with or without AUD. Participants will provide stool and blood samples and answer questions to help researchers understand the gut's role in these health issues. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on gut health and inflammation in HIV and AUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be able to temporarily stop using antiplatelet or anticoagulant medications for endoscopy. If you are on these medications, discuss with the trial team to see if you can safely pause them.

What prior data suggests that these prebiotics are safe for humans?

Research has shown that prebiotics are generally safe for use. Studies have found that prebiotics are usually well-tolerated and do not cause major side effects. For instance, one study found that a specific prebiotic, Orafti®Synergy1, was safe for infants, suggesting its safety for a wide range of people. Additionally, major health authorities like the FDA recognize prebiotics as safe, allowing their consumption as food supplements. The prebiotic in this trial aims to improve gut health and reduce inflammation, which is particularly important for people living with HIV. Overall, the evidence supports the safety of prebiotics, making them a promising option for improving health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for HIV and Alcohol Use Disorder (AUD), which often involve antiretroviral therapy and behavioral interventions, this study explores the use of a prebiotic called fructooligosaccharides (FOS). FOS is unique because it is a type of fiber that feeds beneficial gut bacteria, potentially improving gut health and immune function. Researchers are excited about this treatment because it might offer a simple, dietary approach to support overall health in people living with HIV, especially those managing additional challenges like AUD. This could represent a novel way to enhance traditional treatments by targeting gut microbiota.

What evidence suggests that this prebiotic is effective for reducing gut inflammation in people with HIV and AUD?

Research has shown that prebiotics can maintain gut health and reduce inflammation, particularly in people with HIV. One study demonstrated that prebiotics protected the gut from alcohol's harmful effects by reducing oxidative stress, a type of cell damage. These prebiotics are safe and have been found to lower gut inflammation in people. In this trial, some participants with HIV and alcohol use disorder (AUD) will receive a commercially available prebiotic (FOS) for 10 days. Maintaining gut health is crucial for those with HIV, as it may help reduce inflammation-related issues. Thus, prebiotics could be a beneficial addition for individuals with both HIV and AUD. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people aged 45-70 with HIV on ART therapy for at least a year, with stable treatment and undetectable viral load for six months. It's also open to HIV-negative individuals matching the same age, lifestyle, and health criteria. Excluded are those with certain medical conditions or risks related to endoscopy, substance abuse issues, recent vaccines or infections, immunosuppressive treatments, alcoholism including binging behavior.

Inclusion Criteria

HIV+ Group: Ability and willingness to provide informed consent

I am HIV positive, confirmed by tests.

I have been on HIV treatment for at least a year.

Exclusion Criteria

I have had surgery on my digestive system.

I am unable to sign a consent form.

Any condition that, in the opinion of the gastrointestinal (GI) specialist, would either be a contraindication to endoscopy or would increase the risk from sedation, endoscopy, or mucosal biopsies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prebiotic Intervention

Participants receive a commercially available prebiotic (FOS) for 10 days

10 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in plasma and stool SCFA levels, stool and intestinal microbiota composition, and intestinal permeability

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prebiotic

Trial Overview

The study tests if prebiotics can improve gut health and reduce inflammation in people living with HIV who may also have an alcohol use disorder (AUD). Participants will consume prebiotics for ten days and provide stool samples and blood draws during two visits. The larger study includes both HIV-positive/negative groups with/without AUD to compare intestinal resilience against alcohol-induced damage.

How Is the Trial Designed?

Group I: HIV-infected ART-suppressed individuals with no AUD Experimental Treatment 1 Intervention

Only 10 HIV+ ART+,AUD - individuals will be invited to take part in a prebiotic sub study, which they will take a commercially available prebiotic (FOS) for 10 days

Group II: HIV-infected ART-suppressed individuals with AUD Experimental Treatment 1 Intervention

Only 10 HIV+ ART+,AUD + individuals will be invited to take part in a prebiotic sub study, which they will take a commercially available prebiotic (FOS) for 10 days

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study using fecal cultures from healthy and morbidly obese adults, different prebiotics were tested, revealing that 1-kestose had the most significant impact on gut microbiota composition and metabolic activity.

Prebiotic modulation led to increased Bacteroides and Faecalibacterium in obese individuals, while normal-weight individuals showed higher levels of Bifidobacterium and Faecalibacterium, highlighting the need for tailored prebiotic treatments based on individual microbiota profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Evaluation of Different Prebiotics on the Modulation of Gut Microbiota Composition and Function in Morbid Obese and Normal-Weight Subjects. Nogacka, AM., Salazar, N., Arboleya, S., et al.[2023]

In a study of 66 adult men with functional constipation, a synbiotic preparation significantly increased stool frequency and improved stool consistency after 4 weeks of treatment compared to a placebo.

No adverse effects were reported in the synbiotic group, suggesting it is a safe option for treating functional constipation, but further research is needed to confirm its efficacy in broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synbiotic preparation in men suffering from functional constipation: a randomised controlled trial. Fateh, R., Iravani, S., Frootan, M., et al.[2022]

In a pilot study involving 44 participants, including untreated HIV+ patients and those on antiretroviral therapy, a 6-week prebiotic intervention significantly improved gut microbiota composition, particularly in untreated HIV+ individuals, reducing HIV-associated dysbiosis.

The intervention led to declines in markers of bacterial translocation and T-cell activation, along with increased butyrate production, suggesting that targeting the bacterial butyrate synthesis pathway could be a promising strategy for improving immune function in HIV patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of prebiotics on microbial dysbiosis, butyrate production and immunity in HIV-infected subjects. Serrano-Villar, S., Vázquez-Castellanos, JF., Vallejo, A., et al.[2023]

In a study involving conventional rats, a 2-week intervention with a probiotic mixture supplemented with galacto-oligosaccharide (GOS) significantly increased the previously undetectable levels of bifidobacteria, while lactic acid bacteria levels remained unchanged due to already high baseline numbers.

In healthy human subjects, the probiotic mixture with polydextrose (PDX) led to a notable increase in bifidobacteria and lactic acid bacteria counts, suggesting that the effectiveness of pro- and prebiotics depends on the initial levels of these bacteria, and highlighting the importance of tailored combinations for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of prebiotic supplementation on a probiotic bacteria mixture: comparison between a rat model and clinical trials. Tiihonen, K., Suomalainen, T., Tynkkynen, S., et al.[2016]

Infants consuming formula with prebiotics (galacto-oligosaccharides and fructo-oligosaccharides) showed a significantly higher abundance and proportion of beneficial bifidobacteria compared to those without prebiotics, indicating a positive effect on gut microbiota composition.

The prebiotic-containing formula was well tolerated and resulted in lower fecal pH, but did not affect stool patterns, tolerance, or growth compared to the control group, suggesting it is a safe option for infant nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of prebiotic-containing infant formula on gastrointestinal tolerance and fecal microbiota in a randomized controlled trial. Holscher, HD., Faust, KL., Czerkies, LA., et al.[2020]

Native chicory inulin enhances the production of beneficial short-chain fatty acids, particularly propionic and butyric acid, in the human gut, indicating its prebiotic potential.

Real-time PCR is more effective than traditional culture methods for detecting increases in bifidobacteria populations along the colon, showing that inulin has a significant prebiotic effect from the proximal to distal colon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic effects of chicory inulin in the simulator of the human intestinal microbial ecosystem. de Wiele, TV., Boon, N., Possemiers, S., et al.[2023]

A 6-week prebiotic supplementation significantly improved the gut microbiota in HIV-infected individuals, especially in viremic untreated patients, by increasing the diversity and abundance of active bacteria with beneficial properties.

The prebiotics not only reduced dysbiosis but also enhanced the presence of immunomodulatory bacteria, such as Bifidobacteriaceae, to levels comparable to healthy individuals, indicating a potential therapeutic strategy for managing gut health in HIV patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of HIV, antiretroviral therapy and prebiotics on the active fraction of the gut microbiota. Deusch, S., Serrano-Villar, S., Rojo, D., et al.[2019]

In a study involving 30 obese women over 3 months, treatment with inulin-type fructans (ITF prebiotics) significantly altered gut microbiota composition, increasing beneficial bacteria like Bifidobacterium and Faecalibacterium prausnitzii, which are linked to lower serum lipopolysaccharide levels.

The ITF prebiotics also resulted in a slight decrease in fat mass and changes in plasma metabolites, suggesting that these prebiotics can modestly influence host metabolism and may have implications for obesity and diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. Dewulf, EM., Cani, PD., Claus, SP., et al.[2022]

Inulin-type fructans (ITF) have been shown to positively influence the intestinal microbiota by increasing beneficial bacteria such as Bifidobacterium and Lactobacillus, which can lead to improved gut health and function.

ITF intake is associated with several health benefits, including better intestinal barrier function, improved insulin sensitivity, lower triglycerides, enhanced mineral absorption, and increased feelings of fullness, although more research is needed to understand how chain length affects these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prebiotic Potential of Inulin-Type Fructans: A Systematic Review. Hughes, RL., Alvarado, DA., Swanson, KS., et al.[2023]

In a pilot study involving 57 HIV-1-infected adults, a prebiotic oligosaccharide mixture significantly improved gut microbiota composition, increasing beneficial bifidobacteria and reducing harmful bacteria over 12 weeks.

The treatment also led to a reduction in activated CD4(+) T cells and soluble CD14 levels, along with enhanced natural killer (NK) cell activity, suggesting potential immune system benefits for HAART-naive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific prebiotics modulate gut microbiota and immune activation in HAART-naive HIV-infected adults: results of the "COPA" pilot randomized trial. Gori, A., Rizzardini, G., Van't Land, B., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06139224?term=Short%20Bowel%20Syndrome&aggFilters=status:rec&limit=100&rank=79

Study Details | Gut Microbiota-Mediated Inflammatory ...

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2.

prebioticassociation.org

prebioticassociation.org/whats-the-latest-in-prebiotic-research-april-2025-edition/

What's the Latest in Prebiotic Research? – April 2025 Edition

Alcohol use disorder (AUD) is a chronic, relapsing, psychiatric disorder ... Fifty AUD patients were supplemented with inulin or maltodextrin (placebo) for ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9229734/

Effects of Inulin-Based Prebiotics Alone or in Combination with ...

Both synbiotic (B group) and prebiotic (A group) treatments showed a significant increase between the initial and the final time-points (T0–T56) ...

4.

withpower.com

withpower.com/trial/phase-hiv-infections-10-2023-bf333

Prebiotics for AUD and HIV/AIDS

These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022316623026020

Prebiotic Inulin Enriched with Oligofructose in Combination ...

Our study investigated the effects of PRO, PRE and their combined application [synbiotics (SYN)] at the systemic level and at the GALT level.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06139224

Study Details | NCT06139224 | Gut Microbiota-Mediated ...

Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12207258/

Targeting gut health: Probiotics as promising therapeutics in ...

This review underscores the importance of a multifaceted approach toward understanding alcohol-associated liver diseases and the therapeutic potential of ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8070502/

Long-Term Safety and Efficacy of Prebiotic Enriched Infant ...

The present study thus confirms findings of previous studies reporting that Orafti®Synergy1, at the same dose level, is safe and well-tolerated by neonates [12] ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04055246

NCT04055246 | Measuring Effects of Prebiotics on Human ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... disorder, schizophrenia, bipolar disorder, alcohol or drug dependence, etc) ...

10.

journals.co.za

journals.co.za/doi/10.36303/SAPJ.0138

Emerging paradigms in prebiotics research: implications ...

Prebiotics are Generally Recognized as Safe (GRAS), novel foods and food additives by the Food and Drug Administration (FDA), EU and Japan, ...